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FDA 510(k)

PALESTRANT IRRIGATION AND DRAINAGE SET

K-Number: K896087 · 1989-11-03

ApplicantNorth American Instrument Corp.
Decision Date1989-11-03
Product CodeKGZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PALESTRANT IRRIGATION AND DRAINAGE SET is the device name listed in this FDA 510(k) record. The listed applicant is North American Instrument Corp.. It received FDA 510(k) clearance on 1989-11-03 under 510(k) number K896087. The device is classified under product code KGZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PALESTRANT IRRIGATION AND DRAINAGE SET?

PALESTRANT IRRIGATION AND DRAINAGE SET is a medical device that received FDA 510(k) clearance on 1989-11-03. The listed applicant is North American Instrument Corp.. The 510(k) number is K896087.

When did PALESTRANT IRRIGATION AND DRAINAGE SET receive FDA 510(k) clearance?

PALESTRANT IRRIGATION AND DRAINAGE SET received FDA 510(k) clearance on 1989-11-03, under 510(k) number K896087.

Who is the listed applicant for PALESTRANT IRRIGATION AND DRAINAGE SET?

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

What is the FDA product code for PALESTRANT IRRIGATION AND DRAINAGE SET?

The FDA product code for PALESTRANT IRRIGATION AND DRAINAGE SET is KGZ.

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Other records listing North American Instrument 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.

K960801SELECTOR ANGIOGRAPHIC CATHETER (VARIOUS MODELS)K955554HEMO-VALVEK960310EPIC INTRODUCER SHEATHK922552MORSE(R) ANGIOGRAPHIC CATHETERSK915078MORSE HEMOSTATIC CATHETER INTRODUCER SETK905208MORSE ANESTHESIA

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Related Devices (Code: KGZ)

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.

K022306AART SILICONE TUBINGAesthetic and Reconstructive Technologies, Inc.K974295BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBINGByron MedicalK973183WOUND DRAINAGE HOLDERR & D Medical Products, Inc.K955433DURALASTIC SILICONE TUBINGAllied Biomedical Corp.K942315NAVARRE PERCUTANEOUS ACCESS SETNavarre Biomedical , Ltd.K895041OPTICAL CATHETER(TM) INTRODUCER SETSMedical Dynamics, 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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