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FDA 510(k)

DA-16 AND DA-24 SHUNT ADAPTERS

K-Number: K893478 · 1989-06-08

ApplicantAkcess Medical Products, Inc.
Decision Date1989-06-08
Product CodeFKN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DA-16 AND DA-24 SHUNT ADAPTERS 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 1989-06-08 under 510(k) number K893478. The device is classified under product code FKN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DA-16 AND DA-24 SHUNT ADAPTERS?

DA-16 AND DA-24 SHUNT ADAPTERS is a medical device that received FDA 510(k) clearance on 1989-06-08. The listed applicant is Akcess Medical Products, Inc.. The 510(k) number is K893478.

When did DA-16 AND DA-24 SHUNT ADAPTERS receive FDA 510(k) clearance?

DA-16 AND DA-24 SHUNT ADAPTERS received FDA 510(k) clearance on 1989-06-08, under 510(k) number K893478.

Who is the listed applicant for DA-16 AND DA-24 SHUNT ADAPTERS?

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 DA-16 AND DA-24 SHUNT ADAPTERS?

The FDA product code for DA-16 AND DA-24 SHUNT ADAPTERS is FKN.

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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: FKN)

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.

K892667SAF-T-SHUNT SILICONE RUBBER U, PROD. CODE S-313Akcess Medical Products, Inc.K813428SHUNT ADAPTERQuinton, Inc.K771425A-V SHUNT EXTENSIONQuinton, 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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