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FDA 510(k)

PERITONEAL INTRODUCER & SHEATH

K-Number: K771529 · 1977-08-16

ApplicantCordis Corp.
Decision Date1977-08-16
Product CodeGYK
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PERITONEAL INTRODUCER & SHEATH is the device name listed in this FDA 510(k) record. The listed applicant is Cordis Corp.. It received FDA 510(k) clearance on 1977-08-16 under 510(k) number K771529. 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 PERITONEAL INTRODUCER & SHEATH?

PERITONEAL INTRODUCER & SHEATH is a medical device that received FDA 510(k) clearance on 1977-08-16. The listed applicant is Cordis Corp.. The 510(k) number is K771529.

When did PERITONEAL INTRODUCER & SHEATH receive FDA 510(k) clearance?

PERITONEAL INTRODUCER & SHEATH received FDA 510(k) clearance on 1977-08-16, under 510(k) number K771529.

Who is the listed applicant for PERITONEAL INTRODUCER & SHEATH?

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

What is the FDA product code for PERITONEAL INTRODUCER & SHEATH?

The FDA product code for PERITONEAL INTRODUCER & SHEATH is GYK.

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Other records listing Cordis 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.

K112797POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETERK101651ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE, ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIREK082143MICRO GUIDE CATHETER XPK062798SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MBK060877PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL PB1550,BAS,BAX,PB1560,BAS,BAX,PB1850,BAS,BAXPB1860BAS,BAXK050645CORDIS AMIIA .014 PTA BALLOON CATHETER

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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 CorpK883607PEEL-AWAY INTRODUCER FOR VENTRICULAR CATHETERCodman & Shurtleff, 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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