510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K993966Substantially Equivalent

8Fr. Narrowflex Universal Intra-Aortic Balloon Catheter

Arrow Intl., Inc., Everett MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K993966 is the FDA 510(k) clearance record for 8FR. NARROWFLEX UNIVERSAL INTRA-AORTIC BALLOON CATHETER, 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 one recall naming K993966.

Clearance record

Decision date
Received
(87 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. 9 Plymouth St., Everett MA
510(k) summary
Summary
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 October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DSP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260