510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K200634Substantially Equivalent

Arrow FiberOptix Intra-Aortic Balloon Catheter Kit

Arrow International LLC (subsidiary of Teleflex Incorporated), Chelmsford MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K200634 is the FDA 510(k) clearance record for Arrow FiberOptix Intra-Aortic Balloon Catheter Kit, a class II device, cleared for Arrow International, Inc. on under FDA product code DSP (System, Balloon, Intra-Aortic And Control). FDA records list 23 510(k) clearances for Arrow International LLC (subsidiary of Teleflex Incorporated), from to . As of , FDA records show one recall naming K200634.

Clearance record

Decision date
Received
(30 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 International, Inc. 16 Elizabeth Dr., Chelmsford MA
510(k) summary
Summary PDF
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