510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K960479Substantially Equivalent

Arrow Bipolar Pacing/balloon Wedge Pressure Catheter

Arrow Intl., Inc., Reading PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K960479 is the FDA 510(k) clearance record for ARROW BIPOLAR PACING/BALLOON WEDGE PRESSURE CATHETER, a class II device, cleared for Arrow Intl., Inc. on under FDA product code LDF (Electrode, Pacemaker, Temporary). FDA records list 111 510(k) clearances for Arrow Intl., Inc., from to . As of , FDA records show 4 recalls naming K960479.

Clearance record

Decision date
Received
(258 days to decision)
Product code
LDF Electrode, Pacemaker, Temporary
Regulation
21 CFR 870.3680
Device class
Class II
Review panel
Cardiovascular
Applicant
Arrow Intl., Inc. 3000 Bernville Rd., Reading PA
510(k) summary
Summary
Third party review
No

Clearances, product code LDF

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