FDA 510(k) Applications Submitted by Amy Ma
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K132853 |
09/12/2013 |
NOVAPACS |
NOVARAD CORP. |
| K222456 |
08/15/2022 |
High Protection Surgical Gown |
3A Medical Products Co., Ltd |
| K142554 |
09/11/2014 |
Revolution Full Face Mask |
Respironics, Inc. |
| K210601 |
03/01/2021 |
Plato 17 Microcatheter |
Scientia Vascular LLC |
| K201760 |
06/29/2020 |
Zoom 14 Guidewire |
Scientia Vascular LLC |
| K142445 |
09/02/2014 |
PINPOINT GT SAFETY INTRODUCER NEEDLE |
C.R. BARD, INC. |
| K192783 |
09/30/2019 |
Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm, Standard Profile ; Aristotle 24 Guidewire, 200cm, Support Profile |
Scientia Vascular LLC |
| K193194 |
11/19/2019 |
CrossTorq 14 Guidewire |
Scientia Cardio Access LLC |
| K000734 |
03/07/2000 |
PIONEER SURGICAL TECHNOLOGY EXTENDED GTR, MODEL 501-601 |
PIONEER SURGICAL TECHNOLOGY |
| K993286 |
10/01/1999 |
PIONEER SILICOAT STERNAL CABLE |
PIONEER SURGICAL TECHNOLOGY |
| K001709 |
06/05/2000 |
TROCHANTERIC REATTACHMENT DEVICE (STANDARD) AND (LONG), MODEL 501-066, 501-067 |
PIONEER SURGICAL TECHNOLOGY |
| K002110 |
07/12/2000 |
SPL CRIMP SYSTEM |
PIONEER SURGICAL TECHNOLOGY |
| K003496 |
11/13/2000 |
CANNULATED SCREW SYSTEM |
PIONEER SURGICAL TECHNOLOGY |
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