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FDA 510(k)

HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSE

K-Number: K895868 · 1989-10-31

ApplicantBaxter Healthcare Corp
Decision Date1989-10-31
Product CodeGYK
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSE is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1989-10-31 under 510(k) number K895868. 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 HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSE?

HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSE is a medical device that received FDA 510(k) clearance on 1989-10-31. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K895868.

When did HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSE receive FDA 510(k) clearance?

HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSE received FDA 510(k) clearance on 1989-10-31, under 510(k) number K895868.

Who is the listed applicant for HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSE?

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

What is the FDA product code for HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSE?

The FDA product code for HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSE 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.K883607PEEL-AWAY INTRODUCER FOR VENTRICULAR CATHETERCodman & Shurtleff, Inc.K873771HEYER-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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