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FDA 510(k)

VESSEL DILATORS

K-Number: K910502 · 1991-04-29

ApplicantAkcess Medical Products, Inc.
Decision Date1991-04-29
Product CodeFKA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VESSEL DILATORS is the device name listed in this FDA 510(k) record. The listed applicant is Akcess Medical Products, Inc.. It received FDA 510(k) clearance on 1991-04-29 under 510(k) number K910502. The device is classified under product code FKA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VESSEL DILATORS?

VESSEL DILATORS is a medical device that received FDA 510(k) clearance on 1991-04-29. The listed applicant is Akcess Medical Products, Inc.. The 510(k) number is K910502.

When did VESSEL DILATORS receive FDA 510(k) clearance?

VESSEL DILATORS received FDA 510(k) clearance on 1991-04-29, under 510(k) number K910502.

Who is the listed applicant for VESSEL DILATORS?

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

What is the FDA product code for VESSEL DILATORS?

The FDA product code for VESSEL DILATORS is FKA.

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Other records listing Akcess Medical Products, 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.

K926374SILICONE CATHETER REPAIR KITSK925819AKCESS0CATH KITK925818AKCESS-CATHK930630RIGHT ATRIAL CATHETERK931120COAXIAL ACUTE CATHETERK920634SPLITTABLE SHEATH INTRODUCER SET

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Related Devices (Code: FKA)

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.

K022620SHEATHLESS ACCESSORY KIT, MODELS XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 AND XRIKRTSpire Biomedical, Inc.K914210VAS-CATH DUALATOR(TM) VESSEL DILATORVas-Cath, 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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