510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K960713Substantially Equivalent

8 Fr.-40Cc Arrow Flex Intra-Aortic Balloon Catheter with Blue Flex Tip, Product Number Iab-04840(Used with a 9Fr.sheath)

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

K960713 is the FDA 510(k) clearance record for 8 FR.-40CC ARROW FLEX INTRA-AORTIC BALLOON CATHETER WITH BLUE FLEX TIP, PRODUCT NUMBER IAB-04840(USED WITH A 9FR.SHEATH), a class II device, cleared for Arrow Intl., Inc. on under FDA product code DSP (System, Balloon, Intra-Aortic And Control). FDA records list 111 510(k) clearances for Arrow Intl., Inc., from to . As of , FDA records show no recalls naming K960713.

Clearance record

Decision date
Received
(84 days to decision)
Product code
DSP System, Balloon, Intra-Aortic And Control
Regulation
21 CFR 870.3535
Device class
Class II
Review panel
Cardiovascular
Applicant
Arrow Intl., Inc. 3000 Bernville Rd., Reading PA
510(k) summary
Statement
Third party review
No

Clearances, product code DSP

Trailing 12 months

FDA records hold no clearances under product code DSP in the trailing twelve months.

FDA records show no clearances under product code DSP in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DSP, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260