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FDA 510(k)

CUFF MATERIAL ON PEDIATRIC SIZE CATH.

K-Number: K812718 · 1981-10-19

ApplicantQuinton, Inc.
Decision Date1981-10-19
Product CodeFJS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CUFF MATERIAL ON PEDIATRIC SIZE CATH. is the device name listed in this FDA 510(k) record. The listed applicant is Quinton, Inc.. It received FDA 510(k) clearance on 1981-10-19 under 510(k) number K812718. The device is classified under product code FJS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CUFF MATERIAL ON PEDIATRIC SIZE CATH.?

CUFF MATERIAL ON PEDIATRIC SIZE CATH. is a medical device that received FDA 510(k) clearance on 1981-10-19. The listed applicant is Quinton, Inc.. The 510(k) number is K812718.

When did CUFF MATERIAL ON PEDIATRIC SIZE CATH. receive FDA 510(k) clearance?

CUFF MATERIAL ON PEDIATRIC SIZE CATH. received FDA 510(k) clearance on 1981-10-19, under 510(k) number K812718.

Who is the listed applicant for CUFF MATERIAL ON PEDIATRIC SIZE CATH.?

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

What is the FDA product code for CUFF MATERIAL ON PEDIATRIC SIZE CATH.?

The FDA product code for CUFF MATERIAL ON PEDIATRIC SIZE CATH. is FJS.

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Other records listing Quinton, Inc. as applicant

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Related Devices (Code: FJS)

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.

K213602Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool KitCovidien, LLCK180485Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialysis Catheter and Kits, Argyle Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter, Argyle Adult Peritoneal Dialysis Accessory Titanium Catheter ExtenderCovidien, LLCK130441FALLER STYLETMedionics International, Inc.K121383PS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CATHETER WITH ALL COMPONENTS)Medical Components, Inc.K120130FALLER TROCARMedigroup, Inc.K113354VETA PERITONEAL DIALYSIS CATHETERPfm Medical, 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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