BIB PTA BALLOON CATHETER— 510(k) K050857

Unknown

NuMED, Inc.

FDA 510(k) clearance K050857 for BIB PTA BALLOON CATHETER, Unknown on 2005-07-28. Applicant: NuMED, Inc.. Device class: 2.

Clearance details

Applicant: NuMED, Inc.
Product code: Code NVM
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 2005-04-05
Decision date: 2005-07-28
Decision: Unknown
Clearance type: Traditional
Location: Hopkinton, NY, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K050857

K-number listed on FDA's recall record

Z-1754-2025 — BIB Balloon in Balloon Dilatation Catheter. Model Number: 420Class II·Terminated·Numed Inc·20250421

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K050857.

Data sourced from openFDA. This site is unofficial and independent of the FDA.