Silk Road Medical

FDA Device Registration & Listing · Plymouth, MN, US · Registration 3022627847

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3022627847
FEI Number
3022627847
Entity Name
Silk Road Medical
City/State/Country
Plymouth, MN, US
Establishment Address
14755 27th Avenue North, Plymouth, MN 55447, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Boston Scientific Corporation (Owner Number: 9912058)
Owner / Operator Contact Address
300 Boston Scientific Way, Marlborough, MA 01752, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K221414
PMA Number
N/A

All Registered Proprietary Names

ENROUTE Transcarotid Stent System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NTE Temporary Carotid Catheter For Embolic Capture Cardiovascular Class 2 870.1250 2024-10-14
NIM Stent, Carotid Unknown Class 3 N/A 2024-10-14
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2024-10-14

Official Correspondent

Adrienne Bishop

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Boston Scientific Corporation
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3025434462 Obsidio Inc Maple Grove, MN, US
3005619880 Boston Scientific Corporation Roswell, GA, US
3015425075 NALU MEDICAL Carlsbad, CA, US
3015289131 FARAPULSE, INC. Menlo Park, CA, US
3022298579 Boston Scientific Cardiac Diagnostic Technologies, Inc. Arden Hills, MN, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K171251 Creagh Medical 014 Hydrophilic Coated PTA Balloon Dilatation Catheter 2017-09-08
K103464 Medtronic, Inc. PACIFIC XTREME PTCA BALLOON DILATATION CATHETER 2010-12-22
K252512 ABBOTT MEDICAL Armada™ 14 NC PTA Catheter 2026-02-13
K142654 Covidien, LLC Fortrex 0.035 OTW PTA Balloon Catheter 2014-10-28
K202800 Medtronic Vascular,Inc(Formerly D.B.A Ev3 Inc.,Covidien, LLC) Pacific Plus PTA Catheter 2020-11-18

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0009-2024 Boston Scientific Corporation 2
Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
Z-0010-2024 Boston Scientific Corporation 2
Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter
Z-0011-2024 Boston Scientific Corporation 2
Guider Softip Guide Catheter 8F PRE-SHAPED 40 90CM, Catalog number H965100440, cardiac guide catheter
Z-0012-2024 Boston Scientific Corporation 2
Guider Softip Guide Catheter 6F 90CM MULTI PURPOSE, Catalog number H965100460, cardiac guide catheter
Z-0013-2024 Boston Scientific Corporation 2
Guider Softip Guide Catheter 7F 90CM MULTI PURPOSE, Catalog number H965100470, cardiac guide catheter

Similar Registrations

Registration Number Establishment Name Location
2024024 Sterigenics Radiation Technologies, LLC San Diego, CA, US
1016427 Cordis US Corp. Miami Lakes, FL, US
2183744 Isomedix Operations, Inc. Minneapolis, MN, US
3013556777 MicroVention, Inc. Aliso Viejo, CA, US
2126666 Lake Region Medical CHASKA, MN, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3022627847. Last updated year: 2026. Please use registration number 3022627847 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.