FDA Device Establishments · JSON-LD · Markdown

SPECTRANETICS CORP.

FEI 3007284006 · Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 · Status: Active

FEI Number3007284006
Owner / OperatorPhilips Medical Systems International BV (#2939520)
Address9965 Federal Drive, Colorado Springs, CO, US
Registration expiry2026
Initial importer flagN
Registered products1
Product codes (top 20)MCW
Regulation § (21 CFR)870.4875
Proprietary namesPhoenix Atherectomy Catheter 1.8mm x 130cm; Phoenix Handle with Wire Support Clip; Phoenix Atherectomy Catheter 2.2mm x 130cm; Phoenix Atherectomy System 2.2mm x 130cm; Phoenix Atherectomy System 1.8mm x 130cm

External sources

Source: openFDA. Public-domain (CC0).