FDA 510(k)

VESICO SUPRAPUBIC BLADDER DRAINAGE & EXCHANGE SETS

K-Number: K863386 · 1986-10-24

Decision Date1986-10-24

Product CodeKOB

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

VESICO SUPRAPUBIC BLADDER DRAINAGE & EXCHANGE SETS is the device name listed in this FDA 510(k) record. The listed applicant is Angiomed U.S., Inc.. It received FDA 510(k) clearance on 1986-10-24 under 510(k) number K863386. The device is classified under product code KOB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VESICO SUPRAPUBIC BLADDER DRAINAGE & EXCHANGE SETS?

VESICO SUPRAPUBIC BLADDER DRAINAGE & EXCHANGE SETS is a medical device that received FDA 510(k) clearance on 1986-10-24. The listed applicant is Angiomed U.S., Inc.. The 510(k) number is K863386.

When did VESICO SUPRAPUBIC BLADDER DRAINAGE & EXCHANGE SETS receive FDA 510(k) clearance?

VESICO SUPRAPUBIC BLADDER DRAINAGE & EXCHANGE SETS received FDA 510(k) clearance on 1986-10-24, under 510(k) number K863386.

Who is the listed applicant for VESICO SUPRAPUBIC BLADDER DRAINAGE & EXCHANGE SETS?

The FDA 510(k) record lists Angiomed U.S., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VESICO SUPRAPUBIC BLADDER DRAINAGE & EXCHANGE SETS?

The FDA product code for VESICO SUPRAPUBIC BLADDER DRAINAGE & EXCHANGE SETS is KOB.

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Other records listing Angiomed U.S., Inc. as applicant

K874771ANGIOMED INTRODUCING SETS K874585ANGIOMED OSTY-CUT BONE BIOPSY NEEDLE K864225ANGIOMED URETERAL D&M SETS/URETEROSCOPY GUID STENT K862805ANGIOMED VAC-U-CUT BIOPSY NEEDLE K863446ANGIOMED HIGH PRESSURE CONNECTORS K854910ANGIOFLOW

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Related Devices (Code: KOB)

K240514AMT Low-Profile Suprapubic Catheter & Drainage SetApplied Medical Technology, Inc.K181097Cook Cystostomy Catheter SetCook Incorporated K182709One-Step Suprapubic IntroducerCook Incorporated K182066O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer SetCook Incorporated K120127SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SYSTEMSwan Valley Medical, Incorporated K014002ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890Fortune Medical Instrument Corp.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.