VESICO SUPRAPUBIC BLADDER DRAINAGE & EXCHANGE SETS— 510(k) K863386

Name: FDA 510(k) clearance K863386
Creator: U.S. Food and Drug Administration
Published: 1986-10-24

Substantially Equivalent

Angiomed U.S., Inc.

FDA 510(k) clearance K863386 for VESICO SUPRAPUBIC BLADDER DRAINAGE & EXCHANGE SETS, Substantially Equivalent on 1986-10-24. Applicant: Angiomed U.S., Inc.. Device class: 2.

Clearance details

Applicant: Angiomed U.S., Inc.
Product code: Code KOB
Device class: Class 2
Regulation: 21 CFR 876.5090
Advisory panel: Gastroenterology, Urology
Date received: 1986-09-03
Decision date: 1986-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anaheim, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Angiomed U.S., Inc.

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K874771 — ANGIOMED INTRODUCING SETS1988-01-12
K874585 — ANGIOMED OSTY-CUT BONE BIOPSY NEEDLE1987-12-02
K864225 — ANGIOMED URETERAL D&M SETS/URETEROSCOPY GUID STENT1987-01-30
K862805 — ANGIOMED VAC-U-CUT BIOPSY NEEDLE1986-09-29
K863446 — ANGIOMED HIGH PRESSURE CONNECTORS1986-09-23

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