510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K982419Substantially Equivalent

Heart-Lift Balloon Positioner

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

K982419 is the FDA 510(k) clearance record for HEART-LIFT BALLOON POSITIONER, a class I device, cleared for Cardiothoracic Systems, Inc. on under FDA product code MWS (Stabilizer, Heart). FDA records list 8 510(k) clearances for Cardiothoracic Systems, Inc., from to . As of , FDA records show no recalls naming K982419.

Clearance record

Decision date
Received
(184 days to decision)
Product code
MWS Stabilizer, Heart
Regulation
21 CFR 870.4500
Device class
Class I
Review panel
Cardiovascular
Applicant
Cardiothoracic Systems, Inc. 10600 N. Tantau Ave., Cupertino CA
510(k) summary
Summary
Third party review
No

Clearances, product code MWS

Trailing 12 months

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

FDA records show no clearances under product code MWS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MWS, 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