SPECTRANETICS CORP.

FDA Device Registration & Listing · FREMONT, CA, US · Registration 3005462046

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
3005462046
FEI Number
3005462046
Entity Name
SPECTRANETICS CORP.
City/State/Country
FREMONT, CA, US
Establishment Address
5055 BRANDIN COURT, FREMONT, CA 94538, US
Establishment Type(s)
Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Philips Medical Systems International BV (Owner Number: 2939520)
Owner / Operator Contact Address
Veenpluis 6, Best, NL-NOTA 5684PC, NL
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
P050018

All Registered Proprietary Names

Angiosculpt PTCA RX Scoring Balloon Catheter

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NWX Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring Unknown Class 3 N/A 2018-11-26

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Philips Medical Systems International BV
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3038281851 Philips Polska Sp. z o.o. Lodz Lodzkie, PL
3003584029 Braemar Manufacturing, LLC San Diego, CA, US
3042175841 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Best Noord-Brabant, NL
3008514395 Telcare, LLC Linwood, PA, US
3004961434 RESPIRATORY TECHNOLOGIES, INC. Plymouth, MN, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005462046. Last updated year: 2026. Please use registration number 3005462046 when referencing this establishment in official correspondence.
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