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510(k) K892667

SAF-T-SHUNT SILICONE RUBBER U, PROD. CODE S-313 by Akcess Medical Products, Inc. — Product Code FKN

K892667 is an FDA 510(k) premarket notification submitted by Akcess Medical Products, Inc. for the device "SAF-T-SHUNT SILICONE RUBBER U, PROD. CODE S-313". The FDA issued a decision of Substantially Equivalent on May 4, 1989. The device falls under product code FKN (Adaptor, Shunt), a Class II device regulated under 21 CFR 876.5540. Akcess Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 1989
Date Received
April 13, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Adaptor, Shunt
Device Class
Class II
Regulation Number
876.5540
Review Panel
GU
Submission Type

Other clearances by Akcess Medical Products, Inc.

  • K926374 — SILICONE CATHETER REPAIR KITS (October 7, 1994)
  • K925819 — AKCESS0CATH KIT (August 2, 1994)
  • K925818 — AKCESS-CATH (April 5, 1994)
  • K930630 — RIGHT ATRIAL CATHETER (February 7, 1994)
  • K920634 — SPLITTABLE SHEATH INTRODUCER SET (January 14, 1994)
  • K931120 — COAXIAL ACUTE CATHETER (January 14, 1994)
  • K914936 — CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH SET (April 23, 1992)
  • K920331 — RIGHT ATRIAL CATHETER KITS (April 22, 1992)
  • K914826 — AKCESS-CATH KIT (April 10, 1992)
  • K915215 — CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH. KITS (March 27, 1992)

Other clearances for product code FKN

  • K893478 — DA-16 AND DA-24 SHUNT ADAPTERS (June 8, 1989)
  • K813428 — SHUNT ADAPTER (December 31, 1981)
  • K771425 — A-V SHUNT EXTENSION (January 3, 1978)

FDA data resources