| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3022627847 | 3022627847 | Silk Road Medical | 1 | Y | 2026-01-01 | 14755 27th Avenue North Plymouth MN US 55447 |
| 3014526664 | 3007215228 | SILK ROAD MEDICAL, INC. | 1 | Y | 2020-04-25 | 1213 Innsbruck Drive Sunnyvale CA US 94089 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00811311020461 | ENROUTE Transcarotid Stent - 8 mm X 30 mm | 1-855-410-8227 | customerservice@silkroadmed.com |
| 00811311020478 | ENROUTE Transcarotid Stent - 8 mm X 40 mm | 1-855-410-8227 | customerservice@silkroadmed.com |
| 00811311020485 | ENROUTE Transcarotid Stent - 9 mm X 20 mm | 1-855-410-8227 | customerservice@silkroadmed.com |
| 00811311020492 | ENROUTE Transcarotid Stent - 9 mm X 30 mm | 1-855-410-8227 | customerservice@silkroadmed.com |
| 00811311020508 | ENROUTE Transcarotid Stent - 9 mm X 40 mm | 1-855-410-8227 | customerservice@silkroadmed.com |
| 00811311020515 | ENROUTE Transcarotid Stent - 10 mm X 20 mm | 1-855-410-8227 | customerservice@silkroadmed.com |
| 00811311020522 | ENROUTE Transcarotid Stent - 10 mm X 30 mm | 1-855-410-8227 | customerservice@silkroadmed.com |
| 00811311020539 | ENROUTE Transcarotid Stent - 10 mm X 40 mm | 1-855-410-8227 | customerservice@silkroadmed.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 219886 | 1426590073 | P140026 | ENROUTE TRANSCAROTID STENT SYSTEM | NIM | 2015-05-18 |
| 332133 | 1674222266 | P140026 | ENROUTE TRANSCAROTID STENT SYSTEM | NIM | 2015-05-18 |
| 332133 | 1471279712 | K221414 | ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter | LIT | 2022-09-02 |
| 219886 | 1986355887 | K160643 | ENROUTE 0.014 Guidewire | DQX | 2016-10-18 |
| 332133 | 1141042713 | K153485 | ENROUTE Transcarotid Neuroprotection System | NTE | 2016-03-10 |
| 219886 | 1897725112 | K153485 | ENROUTE Transcarotid Neuroprotection System | NTE | 2016-03-10 |
SILK ROAD MEDICAL, INC1213 Innsbruck Drivesunnyvale, CA 94089 PMA NumberP140026 Supplement NumberS026 Date Received12/08/2022 Decision Date12/16/2022 Product Code NIM Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process ...
SILK ROAD MEDICAL, INC1213 Innsbruck Drivesunnyvale, CA 94089 PMA NumberP140026 Supplement NumberS025 Date Received11/21/2022 Decision Date12/16/2022 Product Code NIM Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process ...
SILK ROAD MEDICAL, INC735 North Pastoria Avesunnyvale, CA 94085 PMA NumberP140026 Supplement NumberS021 Date Received06/13/2022 Decision Date06/24/2022 Product Code NIM Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Proces...
SILK ROAD MEDICAL, INC735 North Pastoria Avesunnyvale, CA 94085 PMA NumberP140026 Supplement NumberS019 Date Received04/22/2022 Decision Date05/03/2022 Product Code NIM Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Proces...
SILK ROAD MEDICAL, INC
SILK ROAD MEDICAL, INC
SILK ROAD MEDICAL, INC
SILK ROAD MEDICAL, INC
SILK ROAD MEDICAL, INC
SILK ROAD MEDICAL, INC
SILK ROAD MEDICAL, INC
SILK ROAD MEDICAL, INC
SILK ROAD MEDICAL, INC
SILK ROAD MEDICAL, INC
SILK ROAD MEDICAL, INC
SILK ROAD MEDICAL, INC
SILK ROAD MEDICAL, INC
SILK ROAD MEDICAL, INC
SILK ROAD MEDICAL, INC
SILK ROAD MEDICAL, INC
SILK ROAD MEDICAL, INC
Silk Road Medical
Silk Road Medical, Inc.
SILK ROAD MEDICAL, INC.
SILK ROAD MEDICAL, INC
SILK ROAD MEDICAL, INC
SILK ROAD MEDICAL, INC
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