510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K933033Substantially Equivalent

Guiding Catheter Hemostasis Valve Cap

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

K933033 is the FDA 510(k) clearance record for GUIDING CATHETER HEMOSTASIS VALVE CAP, a class II device, cleared for Arrow Intl., Inc. on under FDA product code DQY (Catheter, Percutaneous). FDA records list 111 510(k) clearances for Arrow Intl., Inc., from to . As of , FDA records show no recalls naming K933033.

Clearance record

Decision date
Received
(80 days to decision)
Product code
DQY Catheter, Percutaneous
Regulation
21 CFR 870.1250
Device class
Class II
Review panel
Cardiovascular
Applicant
Arrow Intl., Inc. P.O. Box 12888, Reading PA
510(k) summary
Statement
Third party review
No

Clearances, product code DQY

Trailing 12 months
13 clearances under product code DQY in the twelve months to November 2026, July 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code DQY, trailing twelve months
MonthClearances
December 20252
January 20260
February 20260
March 20261
April 20262
May 20260
June 20262
July 20263
August 20262
September 20261
October 20260
November 20260