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FDA 510(k)

INTRODUCTION/DRAINAGE CATHETER & ACCESS

K-Number: K881873 · 1988-05-18

ApplicantSheridan Catheter Corp.
Decision Date1988-05-18
Product CodeGBS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

INTRODUCTION/DRAINAGE CATHETER & ACCESS is the device name listed in this FDA 510(k) record. The listed applicant is Sheridan Catheter Corp.. It received FDA 510(k) clearance on 1988-05-18 under 510(k) number K881873. The device is classified under product code GBS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTRODUCTION/DRAINAGE CATHETER & ACCESS?

INTRODUCTION/DRAINAGE CATHETER & ACCESS is a medical device that received FDA 510(k) clearance on 1988-05-18. The listed applicant is Sheridan Catheter Corp.. The 510(k) number is K881873.

When did INTRODUCTION/DRAINAGE CATHETER & ACCESS receive FDA 510(k) clearance?

INTRODUCTION/DRAINAGE CATHETER & ACCESS received FDA 510(k) clearance on 1988-05-18, under 510(k) number K881873.

Who is the listed applicant for INTRODUCTION/DRAINAGE CATHETER & ACCESS?

The FDA 510(k) record lists Sheridan Catheter Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INTRODUCTION/DRAINAGE CATHETER & ACCESS?

The FDA product code for INTRODUCTION/DRAINAGE CATHETER & ACCESS is GBS.

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Other records listing Sheridan Catheter Corp. as applicant

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Related Devices (Code: GBS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K912645ATRIUMS PDR THORACIC CATHETERAtrium Medical Corp.K883887AXIOM ATRAUM WOUND DRAINSAxiom, Inc.K880895URESIL WOUND DRAIN TROCARUresil Corp.K880376NOVO VIVO SUCTION CATHETER VESSEL W/MUCOSE TRAPGenesis Industries, Inc.K873377CLOSED CHEST DRAINAGE SET W/SUTURESGish Biomedical, Inc.K872460AN3000 MAHONEY DRAINH.W. Andersen Products, Inc.

Official Source

View on FDA Database →

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

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