Data / Medical devices / United States / Spectranetics Corp.

Spectranetics Corp.: FDA-registered device maker in Fremont, CA, United States, 1 510(k) clearance and 1 PMA approval

Name: Spectranetics Corp. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Spectranetics Corp. is registered with the FDA (registration 3005462046) in Fremont, CA, United States. It lists 2 device types. The FDA files 1 510(k) clearance and 1 PMA approval under its listings, the newest dated April 8, 2015. 4 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3005462046
Address: 5055 Brandin Court, Fremont, CA, United States, 94538
Owner or operator: Philips Medical Systems International BV (2939520)
Roles: Complaint file establishment, Manufacturer
First device listed: November 26, 2018
Registered through: 2026
Brand names listed: Angiosculpt OTW PTA Scoring Balloon Catheter, Angiosculpt PTCA RX Scoring Balloon Catheter

Devices it lists

Device	Product code	Class	Role	Source
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring	NWX	3	Complaint file establishment, Manufacturer	accessdata.fda.gov
Catheter, Percutaneous, Cutting/Scoring	PNO	2	Complaint file establishment, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 8, 2015	K150634	AngioSculpt PTA Scoring Baloon Catheters	PNO	Substantially Equivalent	Spectranetrics	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
January 8, 2007	P050018	ANGIOSCULPT SCORING BALLOON CATHETER	NWX	32	April 4, 2025	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
December 7, 2018	84057	Class II	Terminated	Spectranetics AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diameter 2.5mm, balloon length 15mm, REF 2027-2515, Sterile, Rx. The firm name on the label is Spectranetics Corporation, Fremont, CA.	The incorrect outer carton box was used for the product.	accessdata.fda.gov
November 16, 2010	57271	Not yet classified	Terminated	AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 137 cm, 4.0 mm x 20 mm balloon size. Part (REF) number: 2076-4020	Reports of distal bond failure which has resulted in peeling of the bond and/or detachment of the distal end of the scoring element. May result in vessel injury or embolism.	accessdata.fda.gov
December 4, 2009	54687	Not yet classified	Terminated	AngioSculpt Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter, cutting/scoring, Easy Exchange (EX) delivery system, Manufactured by AngioScore, Fremont, CA. Catheter is for use in the treatment of hemodynami	Separations of the PTCA catheter shaft at the guide wire exit port have occurred during treatment of coronary artery stenosis. Fragments of the catheter may become lodged in coronary arteries, which resulting in serious patient outcome and require emergency coronary bypass surgery and medical intervention to remove the retained device fragments.	accessdata.fda.gov
November 13, 2007	46149	Not yet classified	Terminated	AngioSculpt PTCA Scoring Balloon Catheter, Catalog (REF) Number: 2027-2510, size 2.5mm x 10 mm, AngioScore, Inc., Fremont, CA.	Mis-labeling: Product labeling on product pouch indicates wrong size, the correct size is on the product carton	accessdata.fda.gov

Compare with other makers

Updated April 4, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.