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FDA 510(k)

DIALY-NATE SET & DIALY-NATE CATHETER

K-Number: K872221 · 1987-10-13

ApplicantGesco Intl., Inc.
Decision Date1987-10-13
Product CodeFKO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DIALY-NATE SET & DIALY-NATE CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Gesco Intl., Inc.. It received FDA 510(k) clearance on 1987-10-13 under 510(k) number K872221. The device is classified under product code FKO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIALY-NATE SET & DIALY-NATE CATHETER?

DIALY-NATE SET & DIALY-NATE CATHETER is a medical device that received FDA 510(k) clearance on 1987-10-13. The listed applicant is Gesco Intl., Inc.. The 510(k) number is K872221.

When did DIALY-NATE SET & DIALY-NATE CATHETER receive FDA 510(k) clearance?

DIALY-NATE SET & DIALY-NATE CATHETER received FDA 510(k) clearance on 1987-10-13, under 510(k) number K872221.

Who is the listed applicant for DIALY-NATE SET & DIALY-NATE CATHETER?

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

What is the FDA product code for DIALY-NATE SET & DIALY-NATE CATHETER?

The FDA product code for DIALY-NATE SET & DIALY-NATE CATHETER is FKO.

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Other records listing Gesco Intl., Inc. 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.

K954422PER-Q-CATH MID-LINEK940870UMBILI-CATHK940953UMBILI-CATH-SK940952UMBILI-CATH-S-DLK941672URI-CATH CATHETERK941232THORA-CATH

View all 26 devices →

Related Devices (Code: FKO)

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.

K964514CORPAK MEDSYSTEMS CRUZ CATHETER FOR PERITONEAL DIALYSISCorpak, Inc.K974570PERITONEAL DIALYSIS CATHETER CONNECTORMedigroup, Inc.K910787TITANIUM CONNECTOR (2 PART)Accurate Surgical Instruments Co.K885037AMUKIN 50% - AIRSPRAY(R)Bernard J. Cooney, P.A.K874650PERITONEAL DIALYSIS KIT (ACUTE AND CHRONIC FORM)Quinton, Inc.K871730MODIFIED USE OF PULL-APART INTRODUCER SETQuinton, 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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