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FDA 510(k)

PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER

K-Number: K930606 · 1993-09-10

ApplicantPudenz-Schulte Medical Research Corp.
Decision Date1993-09-10
Product CodeGYK
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER is the device name listed in this FDA 510(k) record. The listed applicant is Pudenz-Schulte Medical Research Corp.. It received FDA 510(k) clearance on 1993-09-10 under 510(k) number K930606. 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 PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER?

PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER is a medical device that received FDA 510(k) clearance on 1993-09-10. The listed applicant is Pudenz-Schulte Medical Research Corp.. The 510(k) number is K930606.

When did PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER receive FDA 510(k) clearance?

PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER received FDA 510(k) clearance on 1993-09-10, under 510(k) number K930606.

Who is the listed applicant for PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER?

The FDA 510(k) record lists Pudenz-Schulte Medical Research Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER?

The FDA product code for PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER is GYK.

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Other records listing Pudenz-Schulte Medical Research Corp. as applicant

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.

K960055MEDTRONIC PS MEDICAL BIOGLIDE VASCULAR CATHETER, SNGL LUMEN MODEL NOS 8960 & 8932K954409PS MEDICAL IPI VASCULAR ACCESS CATHETERK951258PS MEDICAL BIOGLIDE CSF-FLOW CONTROL SHUNT KITK934167IPI DUAL LUMEN PORTK934796IPI LOW PROFILE IMPORTK940096PS MEDICAL CATHETER PLACEMENT KIT

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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.K932273CORDIS TUNNELERCordis Corp.K895868HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSEBaxter Healthcare CorpK883607PEEL-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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