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FDA 510(k)

ACME GUIDEWIRES FOR PERCUTANEOUS INSERTION OF CATH

K-Number: K883763 · 1988-11-18

ApplicantAcme-Monaco Corp.
Decision Date1988-11-18
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ACME GUIDEWIRES FOR PERCUTANEOUS INSERTION OF CATH is the device name listed in this FDA 510(k) record. The listed applicant is Acme-Monaco Corp.. It received FDA 510(k) clearance on 1988-11-18 under 510(k) number K883763. The device is classified under product code KOD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACME GUIDEWIRES FOR PERCUTANEOUS INSERTION OF CATH?

ACME GUIDEWIRES FOR PERCUTANEOUS INSERTION OF CATH is a medical device that received FDA 510(k) clearance on 1988-11-18. The listed applicant is Acme-Monaco Corp.. The 510(k) number is K883763.

When did ACME GUIDEWIRES FOR PERCUTANEOUS INSERTION OF CATH receive FDA 510(k) clearance?

ACME GUIDEWIRES FOR PERCUTANEOUS INSERTION OF CATH received FDA 510(k) clearance on 1988-11-18, under 510(k) number K883763.

Who is the listed applicant for ACME GUIDEWIRES FOR PERCUTANEOUS INSERTION OF CATH?

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

What is the FDA product code for ACME GUIDEWIRES FOR PERCUTANEOUS INSERTION OF CATH?

The FDA product code for ACME GUIDEWIRES FOR PERCUTANEOUS INSERTION OF CATH is KOD.

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Other records listing Acme-Monaco 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.

K113162SLIDEWIRETM(TRADEMARK PENDING)K920884GUIDEWIRES, VARIOUS TYPESK895854ACME PREFORMED COATED LIGATURE TIES (TOOTH SHADE)K895483ACME COATED ORTHODONTIC ARCHWIRE

Related Devices (Code: KOD)

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.

K251864Rubber Utility CatheterC.R. Bard, Inc.K220036Wellead Ureteral CatheterWell Lead Medical Co., Ltd.K220730allFlex Ureteral Catheters, Krait Ureteral CathetersAllwin Medical Devices, Inc.K211032Urinary Catheter 12 Fr, Urinary Catheter 16 FrUrogen Pharma, Ltd.K181979Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent CatheterTeleflexmedical, Inc.K180354UroGen Ureteral CatheterUrogen Pharma, Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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