510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K081625Substantially Equivalent

Flowpicc Stylet

Teleflex Medical, Sunnyvale CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K081625 is the FDA 510(k) clearance record for FLOWPICC STYLET, a class II device, cleared for Vasonova, Inc. on under FDA product code OBJ (Catheter, Ultrasound, Intravascular). FDA's definition for product code OBJ reads: "For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology". FDA records list 80 510(k) clearances for TELEFLEX MEDICAL, from to . As of , FDA records show no recalls naming K081625.

Clearance record

Decision date
Received
(108 days to decision)
Product code
OBJ Catheter, Ultrasound, Intravascular
Regulation
21 CFR 870.1200
Device class
Class II
Review panel
Cardiovascular
Applicant
Vasonova, Inc. 1368 Bordeaux Dr., Suite 100, Sunnyvale CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OBJ

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