AngioSafe

FDA Device Registration & Listing · San Jose, CA, US · Registration 3013757884

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
3013757884
FEI Number
3013757884
Entity Name
AngioSafe
City/State/Country
San Jose, CA, US
Establishment Address
5215 Hellyer Ave Ste 240, San Jose, CA 95138, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
AngioSafe (Owner Number: 10055439)
Owner / Operator Contact Address
6150 Hellyer Avenue, San Jose, CA 95138, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K252315
PMA Number
N/A

All Registered Proprietary Names

Santreva-ATK Endovascular Revascularization Catheter

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PDU Catheter For Crossing Total Occlusions Cardiovascular Class 2 870.1250 2025-11-17

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

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

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K071227 Spectranetics Corp. CLIRPATH TURBO EXCIMER LASER CATHETER (RX) -0.9MM, (RX) -1.4MM, (RX) -1.7MM, (RX) -2.0MM, MODEL 310-154, 314-159, 317-15 2007-07-11

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013757884. Last updated year: 2026. Please use registration number 3013757884 when referencing this establishment in official correspondence.
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