FDA 510(k) Applications for Medical Device:
Catheter, Thrombus Retriever
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K251015 | Alembic, LLC |
627 National Avenue | Mountain View | CA | 94043 |
| K232971 | Alembic, LLC |
627 National Ave. | Mountain View | CA | 94043 |
| K250958 | Alembic, LLC |
627 National Avenue | Mountain View | CA | 94043 |
| K223545 | Alembic, LLC |
627 National Ave. | Mountain View | CA | 94043 |
| K230695 | Alembic, LLC |
627 National Ave. | Mountain View | CA | 94043 |
| K243287 | Alembic, LLC |
627 National Avenue | Mountain View | CA | 94043 |
| K234083 | Balt USA, LLC |
29 Parker | Irvine | CA | 92618 |
| K243948 | Balt USA, LLC |
29 Parker | Irvine | CA | 92618 |
| K241221 | Cerenovus Inc. |
6303 Waterford District Drive,Suites 215 & 315 | Miami | FL | 33126 |
| K221934 | Cerenovus, Inc. |
6303 Blue Lagoon Drive, Suite 215 & 315 | Miami | FL | 33126 |
| K233988 | Cerenovus, Inc. |
6303 Waterford District Drive, Suites 215 & 315 | Miami | FL | 33216 |
| K193380 | Codman & Shurtleff, Inc. |
325 Paramount Drive | Raynham | MA | 02767 |
| K081305 | CONCENTRIC MEDICAL, INC. |
301 E. EVELYN AVE. | MOUNTAIN VIEW | CA | 94041 |
| K090085 | CONCENTRIC MEDICAL, INC. |
301 E. EVELYN AVE. | MOUNTAIN VIEW | CA | 94041 |
| K033736 | CONCENTRIC MEDICAL, INC. |
1380 SHOREBIRD WAY | MOUNTAIN VIEW | CA | 94043 |
| K082034 | CONCENTRIC MEDICAL, INC. |
301 E. EVELYN AVE. | MOUNTAIN VIEW | CA | 94041 |
| K063774 | CONCENTRIC MEDICAL, INC. |
1380 SHOREBIRD WAY | MOUNTAIN VIEW | CA | 94043 |
| K062046 | CONCENTRIC MEDICAL, INC. |
1380 SHOREBIRD WAY | MOUNTAIN VIEW | CA | 94043 |
| K071172 | CONCENTRIC MEDICAL, INC. |
1380 SHOREBIRD WAY | MOUNTAIN VIEW | CA | 94043 |
| K061059 | CONCENTRIC MEDICAL, INC. |
1380 SHOREBIRD WAY | MOUNTAIN VIEW | CA | 94043 |
| K070521 | CONCENTRIC MEDICAL, INC. |
1380 SHOREBIRD WAY | MOUNTAIN VIEW | CA | 94043 |
| K093610 | CONCENTRIC MEDICAL, INC. |
301 E. EVELYN AVE. | MOUNTAIN VIEW | CA | 94041 |
| K133464 | CONCENTRIC MEDICAL, INC. |
301 E Evelyn Ave | MOUNTAIN VIEW | CA | 94041 |
| K132641 | CONCENTRIC MEDICAL, INC. |
301 E. EVELYN AVE. | MOUNTAIN VIEW | CA | 94041 |
| K122478 | CONCENTRIC MEDICAL, INC. |
301 E Evelyn Ave | MOUNTAIN VIEW | CA | 94041 |
| K120961 | CONCENTRIC MEDICAL, INC. |
301 E Evelyn Ave | MOUNTAIN VIEW | CA | 94041 |
| K150616 | Concentric Medical, Inc. |
301 East Evelyn Avenue | Mountain View | CA | 94041 |
| K143077 | CONCENTRIC MEDICAL, INC. |
301 EAST EVELYN AVENUE | MOUNTAIN VIEW | CA | 94041 |
| K183043 | Imperative Care Inc. |
1359 Dell Avenue | Campbell | CA | 95008 |
| K202182 | Imperative Care Inc. |
1359 Dell Avenue | Campbell | CA | 95008 |
| K210996 | Imperative Care Inc. |
1359 Dell Avenue | Campbell | CA | 95008 |
| K211476 | Imperative Care Inc. |
1359 Dell Avenue | Campbell | CA | 95008 |
| K243047 | Imperative Care, Inc. |
1359 Dell Ave. | Campbell | CA | 95008 |
| K242672 | Imperative Care, Inc. |
1359 Dell Ave | Campbell | CA | 95008 |
| K181354 | InNeuroCo Inc. |
4635 NW 103rd Avenue | Sunrise | FL | 33315 |
| K190338 | InNeuroCo, Inc |
4635 NW 103rd Avenue | Sunrise | FL | 33351 |
| K172167 | InNeuroCo, Inc. |
4635 NW 103rd Avenue | Sunrise | FL | 33351 |
| K123378 | MICRO THERAPEUTICS DBA EV3 NEUROVASCULAR |
9775 TOLEDO WAY | IRVINE | CA | 92618 |
| K113455 | MICRO THERAPEUTICS DBA EV3 NEUROVASCULAR |
9775 TOLEDO WAY | IRVINE | CA | 92618 |
| K243080 | Micro Therapeutics Inc. d/b/a ev3 Neurovascular |
9775 Toledo Way | Irvine | CA | 92618 |
| K141516 | MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR |
9775 TOLEDO WAY | IRVINE | CA | 92618 |
| K201689 | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
9775 Toledo Way | Irvine | CA | 92618 |
| K182101 | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
9775 Toledo Way | Irvine | CA | 92618 |
| K183185 | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
9775 Toledo Way | Irvine | CA | 92618 |
| K180705 | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
9775 Toledo Way | Irvine | CA | 92618 |
| K141491 | MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR |
9775 TOLEDO WAY | IRVINE | CA | 92618 |
| K153071 | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
9775 Toledo Way | Irvine | CA | 92618 |
| K161879 | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
9775 Toledo Way | Irvine | CA | 92618 |
| K160641 | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
9775 Toledo Way | Irvine | CA | 92618 |
| K172448 | Micro Therapeutics, Inc., d/b/a ev3 Neurovascular |
9775 Toledo Way | Irvine | CA | 92618 |
| K211120 | MicroVention Inc. |
35 Enterprise | Aliso Viejo | CA | 92656 |
| K173200 | MicroVention, Inc. |
1311 Valencia Avenue | Tustin | CA | 92780 |
| K212908 | Neuravi Ltd. |
Block 3, Ballybrit Business Park | Galway | H91 K5YD | |
| K211338 | Neuravi Ltd. |
Block 3, Ballybrit Business Park | Galway | H91 K5YD | |
| K173452 | Neuravi Ltd. |
Block 3, Ballybrit Business Park | Galway | ||
| K193063 | Neuravi, Ltd. |
Block 3, Ballybrit Business Park, | Galway | H91 K5YD | |
| K162901 | Penumbra, Inc. |
One Penumbra Place | Alameda | CA | 94502 |
| K072718 | PENUMBRA, INC. |
2401 MERCED ST., SUITE 200 | SAN LEANDRO | CA | 94577 |
| K180008 | Penumbra, Inc. |
One Penumbra Place | Alameda | CA | 94502 |
| K182522 | Penumbra, Inc. |
One Penumbra Place | Alameda | CA | 94502 |
| K090752 | PENUMBRA, INC. |
1351 HARBOR BAY PKWY. | ALAMEDA | CA | 94502 |
| K202251 | Penumbra, Inc. |
One Penumbra Place | Alameda | CA | 94502 |
| K211411 | Penumbra, Inc. |
One Penumbra Place | Alameda | CA | 95132 |
| K222808 | Penumbra, Inc. |
One Penumbra Place | Alameda | CA | 94502 |
| K203440 | Penumbra, Inc. |
One Penumbra Place | Alameda | CA | 94502 |
| K242104 | Penumbra, Inc. |
One Penumbra Place | Alameda | CA | 94502 |
| K211654 | Penumbra, Inc. |
One Penumbra Place | Alameda | CA | 95132 |
| K133317 | PENUMBRA, INC. |
1351 HARBOR BAY PKWY. | ALAMEDA | CA | 94502 |
| K151623 | Penumbra, Inc. |
One Penumbra Place | Alameda | CA | 94502 |
| K190464 | Penumbra, Inc. |
One Penumbra Place | Alameda | CA | 94502 |
| K142458 | PENUMBRA, INC. |
1351 HARBOR BAY PARKWAY | ALAMEDA | CA | 94502 |
| K152541 | PENUMBRA, INC. |
ONE PENUMBRA PLACE | ALAMEDA | CA | 94502 |
| K161064 | Penumbra, Inc. |
One Penumbra Place | Alameda | CA | 94502 |
| K161640 | Penumbra, Inc. |
One Penumbra Place | Alameda | CA | 94502 |
| K113163 | PENUMBRA, INC. |
1351 HARBOR BAY PARKWAY | ALAMEDA | CA | 94502 |
| K191946 | Penumbra, Inc. |
One Penumbra Place | Alameda | CA | 94502 |
| K173761 | Penumbra, Inc. |
One Penumbra Place | Alameda | CA | 94502 |
| K190010 | Penumbra, Inc. |
One Penumbra Place | Alameda | CA | 94502 |
| K100769 | PENUMBRA, INC. |
1351 HARBOR BAY PKWY. | ALAMEDA | CA | 94502 |
| K160449 | PENUMBRA, INC. |
ONE PENUMBRA PLACE | ALAMEDA | CA | 94502 |
| K232524 | Perfuze Ltd. |
Unit 6, Galway Business Park | Galway | H91 W7CP | |
| K250012 | Perfuze Ltd. |
Unit 6, Galway Business Park | Galway | H91 W7CP | |
| K242504 | Perfuze Ltd. |
Unit 6, Galway Business Park | Galway | H91W7CP | |
| K222786 | Q'Apel Medical, Inc. |
4245 Technology Drive | Fremont | CA | 94538 |
| K220808 | Rapid Medical Ltd. |
Carmel Building, POB 337 | Yokneam | 2069205 | |
| K230429 | Rapid Medical Ltd. |
Carmel Building, POB 337 | Yokneam | 2069205 | |
| K203592 | Rapid Medical Ltd. |
Carmel Building, POB 337 | Yokneam | 2069205 | |
| K233329 | Route 92 Medical, Inc. |
155 Bovet Road | San Mateo | CA | 94402 |
| K223530 | Route 92 Medical, Inc. |
155 Bovet Road, Suite 100 | San Mateo | CA | 94402 |
| K243601 | Route 92 Medical, Inc. |
155 Bovet Road | San Mateo | CA | 94402 |
| K223913 | Scientia Vascular Inc |
3487 West 2100 South Suite 100 | West Valley City | UT | 84119 |
| K183464 | Stryker |
47900 Bayside Parkway | Fremont | CA | 94538 |
| K173841 | Stryker |
47900 Bayside Parkway | Fremont | CA | 94538 |
| K190212 | Stryker Neurovascular |
47900 Bayside Parkway | Fremont | CA | 94538 |
| K191768 | Stryker Neurovascular |
47900 Bayside Parkway | Fremont | CA | 94538 |
| K240917 | Wallaby Medical |
22901 Mill Creek Drive | Laguna Hills | CA | 92653 |
| K211697 | Wallaby Medical |
22901 Mill Creek Drive | Laguna Hills | CA | 92653 |
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