510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K161659Substantially Equivalent

FlexSeal Introducer Sheath with Hydrophilic Coating

Libramedical, Inc., Minneapolis MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K161659 is the FDA 510(k) clearance record for FlexSeal Introducer Sheath with Hydrophilic Coating, a class II device, cleared for Libramedical, Inc. on under FDA product code DYB (Introducer, Catheter). FDA records list one 510(k) clearance for Libramedical, Inc. As of , FDA records show no recalls naming K161659.

Clearance record

Decision date
Received
(29 days to decision)
Product code
DYB Introducer, Catheter
Regulation
21 CFR 870.1340
Device class
Class II
Review panel
Cardiovascular
Applicant
Libramedical, Inc. 8401 73rd Ave. N., Minneapolis MN
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code DYB

Trailing 12 months
18 clearances under product code DYB in the twelve months to October 2026, April 2026 the highest month at 7.
Show the numbers
Monthly 510(k) clearances under FDA product code DYB, trailing twelve months
MonthClearances
November 20250
December 20252
January 20261
February 20262
March 20261
April 20267
May 20260
June 20263
July 20262
August 20260
September 20260
October 20260