510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K140351Substantially Equivalent

Arrow Gpscath Balloon Dilatation Catheter

Hotspur Technologies,Inc Subsidiary of Teleflex ME, Mountain View CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K140351 is the FDA 510(k) clearance record for ARROW GPSCATH BALLOON DILATATION CATHETER, a class II device, cleared for Hotspur Technologies,Inc Subsidiary of Teleflex ME on under FDA product code LIT (Catheter, Angioplasty, Peripheral, Transluminal). FDA records list one 510(k) clearance for Hotspur Technologies,Inc Subsidiary of Teleflex ME. As of , FDA records show no recalls naming K140351.

Clearance record

Decision date
Received
(141 days to decision)
Product code
LIT Catheter, Angioplasty, Peripheral, Transluminal
Regulation
21 CFR 870.1250
Device class
Class II
Review panel
Cardiovascular
Applicant
Hotspur Technologies,Inc Subsidiary of Teleflex ME 880 Maude Ave., Suite A, Mountain View CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LIT

Trailing 12 months
5 clearances under product code LIT in the twelve months to October 2026, September 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code LIT, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20262
October 20260