FDA 510(k) Applications for Medical Device:
Catheter, Thrombus Retriever
FDA 510(k) Number |
Applicant |
Address |
City / Country |
State / Province |
Postal Code |
K223545 |
Alembic, LLC |
627 National Ave.
| Mountain View |
CA |
94043 |
K230695 |
Alembic, LLC |
627 National Ave.
| Mountain View |
CA |
94043 |
K221934 |
Cerenovus, Inc. |
6303 Blue Lagoon Drive, Suite 215 & 315
| Miami |
FL |
33126 |
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 |
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 |
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 |
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 |
K222786 |
QÆApel 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 |
K223530 |
Route 92 Medical, Inc. |
155 Bovet Road, Suite 100
| 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 |
K211697 |
Wallaby Medical |
22901 Mill Creek Drive
| Laguna Hills |
CA |
92653 |
|
|