510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K152090Substantially Equivalent

Reprocessed Steerable Introducer

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

K152090 is the FDA 510(k) clearance record for Reprocessed Steerable Introducer, a class II device, cleared for Sterilmed, Inc. on under FDA product code PNE (Reprocessed Catheter Introducer). FDA's definition for product code PNE reads: "Introduce various cardiovascular catheters into the heart and cardiovascular system". FDA records list 65 510(k) clearances for Sterilmed, Inc., from to . As of , FDA records show 2 recalls naming K152090.

Clearance record

Decision date
Received
(240 days to decision)
Product code
PNE Reprocessed Catheter Introducer
Regulation
21 CFR 870.1340
Device class
Class II
Review panel
Cardiovascular
Applicant
Sterilmed, Inc. 5010 Cheshire Pkwy. N., Plymouth MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PNE

Trailing 12 months
2 clearances under product code PNE in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PNE, trailing twelve months
MonthClearances
November 20250
December 20251
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260