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FDA 510(k)

SAF-T-SHUNT SILICONE RUBBER U, PROD. CODE S-313

K-Number: K892667 · 1989-05-04

ApplicantAkcess Medical Products, Inc.
Decision Date1989-05-04
Product CodeFKN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SAF-T-SHUNT SILICONE RUBBER U, PROD. CODE S-313 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 1989-05-04 under 510(k) number K892667. 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 SAF-T-SHUNT SILICONE RUBBER U, PROD. CODE S-313?

SAF-T-SHUNT SILICONE RUBBER U, PROD. CODE S-313 is a medical device that received FDA 510(k) clearance on 1989-05-04. The listed applicant is Akcess Medical Products, Inc.. The 510(k) number is K892667.

When did SAF-T-SHUNT SILICONE RUBBER U, PROD. CODE S-313 receive FDA 510(k) clearance?

SAF-T-SHUNT SILICONE RUBBER U, PROD. CODE S-313 received FDA 510(k) clearance on 1989-05-04, under 510(k) number K892667.

Who is the listed applicant for SAF-T-SHUNT SILICONE RUBBER U, PROD. CODE S-313?

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 SAF-T-SHUNT SILICONE RUBBER U, PROD. CODE S-313?

The FDA product code for SAF-T-SHUNT SILICONE RUBBER U, PROD. CODE S-313 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.

K893478DA-16 AND DA-24 SHUNT ADAPTERSAkcess 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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