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FDA 510(k)

PEEL-AWAY INTRODUCER FOR VENTRICULAR CATHETER

K-Number: K883607 · 1988-09-30

ApplicantCodman & Shurtleff, Inc.
Decision Date1988-09-30
Product CodeGYK
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PEEL-AWAY INTRODUCER FOR VENTRICULAR CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Codman & Shurtleff, Inc.. It received FDA 510(k) clearance on 1988-09-30 under 510(k) number K883607. The device is classified under product code GYK. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PEEL-AWAY INTRODUCER FOR VENTRICULAR CATHETER?

PEEL-AWAY INTRODUCER FOR VENTRICULAR CATHETER is a medical device that received FDA 510(k) clearance on 1988-09-30. The listed applicant is Codman & Shurtleff, Inc.. The 510(k) number is K883607.

When did PEEL-AWAY INTRODUCER FOR VENTRICULAR CATHETER receive FDA 510(k) clearance?

PEEL-AWAY INTRODUCER FOR VENTRICULAR CATHETER received FDA 510(k) clearance on 1988-09-30, under 510(k) number K883607.

Who is the listed applicant for PEEL-AWAY INTRODUCER FOR VENTRICULAR CATHETER?

The FDA 510(k) record lists Codman & Shurtleff, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PEEL-AWAY INTRODUCER FOR VENTRICULAR CATHETER?

The FDA product code for PEEL-AWAY INTRODUCER FOR VENTRICULAR CATHETER is GYK.

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Related Devices (Code: GYK)

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.

K962761REIGEL TUNNELING DEVICECook, Inc.K934391V/P AND L/P CATHETER PASSERSRadionics, Inc.K930606PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSERPudenz-Schulte Medical Research Corp.K932273CORDIS TUNNELERCordis Corp.K895868HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSEBaxter Healthcare CorpK873771HEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTROAmerican V. Mueller

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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