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

Stabilizer, Heart

21 CFR 870.4500 / Cardiovascular
FDA source (opens on fda.gov)

MWS is the FDA product code for Stabilizer, Heart, a class I device type, regulated under 21 CFR 870.4500. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and 17 recalls.

Classification record

Product code
MWS
Device name
Stabilizer, Heart
Regulation
21 CFR 870.4500
Device class
Class I
Review panel
Cardiovascular
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
17

Clearances, product code MWS

By decision year
4 clearances under product code MWS with a decision year between 1999 and 2004, 1999 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code MWS by decision year
YearClearances
19992
20001
20041

Applicants with the most clearances

Product code MWS
Applicants holding the most 510(k) clearances under product code MWS
ApplicantClearances
Cardio Thoracic Systems1
Cardiothoracic Systems, Inc.1
Medtronic, Inc.1
Pilling Weck Surgical1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 36 companies shown, in name order