510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K210047Substantially Equivalent

Stiletto Extended Dwell Catheter

Piper Access, LLC, Salt Lake City UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K210047 is the FDA 510(k) clearance record for Stiletto Extended Dwell Catheter, a class II device, cleared for Piper Access, LLC on under FDA product code PND (Midline Catheter). FDA's definition for product code PND reads: "The catheter is inserted into the peripheral vascular system for infusion of fluids and medications for less than 28 days". FDA records list 3 510(k) clearances for Piper Access, LLC, from to . As of , FDA records show no recalls naming K210047.

Clearance record

Decision date
Received
(231 days to decision)
Product code
PND Midline Catheter
Regulation
21 CFR 880.5200
Device class
Class II
Review panel
General Hospital
Applicant
Piper Access, LLC 6030 W Harold Gatty Dr., Salt Lake City UT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PND

Trailing 12 months
1 clearance under product code PND 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 PND, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260