510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K890021Substantially Equivalent for Some Indications

Sterile Polyhesive Pbs Dressing

Medtronic, Inc., Boulder CO / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K890021 is the FDA 510(k) clearance record for STERILE POLYHESIVE PBS DRESSING, a class III device, cleared for Valleylab, Inc. on under FDA product code KGF (Adhesive, Tissue For Aneurysmorrhaphy). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K890021.

Clearance record

Decision date
Received
(148 days to decision)
Product code
KGF Adhesive, Tissue For Aneurysmorrhaphy
Device class
Class III
Review panel
Unknown
Applicant
Valleylab, Inc. 5920 Longbow Dr., Boulder CO
Third party review
No

Clearances, product code KGF

Trailing 12 months

FDA records hold no clearances under product code KGF in the trailing twelve months.

FDA records show no clearances under product code KGF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KGF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260