510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K983135Substantially Equivalent

Blower/mister

Cardiothoracic Systems, Inc., Cupertino CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K983135 is the FDA 510(k) clearance record for BLOWER/MISTER, a class II device, cleared for Cardiothoracic Systems, Inc. on under FDA product code FQH (Lavage, Jet). FDA records list 8 510(k) clearances for Cardiothoracic Systems, Inc., from to . As of , FDA records show one recall naming K983135.

Clearance record

Decision date
Received
(66 days to decision)
Product code
FQH Lavage, Jet
Regulation
21 CFR 880.5475
Device class
Class II
Review panel
General Hospital
Applicant
Cardiothoracic Systems, Inc. 10600 N. Tantau Ave., Cupertino CA
510(k) summary
Summary
Third party review
No

Clearances, product code FQH

Trailing 12 months
2 clearances under product code FQH in the twelve months to October 2026, February 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FQH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20262
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260