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

Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement

21 CFR 870.3470 / Cardiovascular
FDA source (opens on fda.gov)

PAW is the FDA product code for Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement, a class II device type, regulated under 21 CFR 870.3470. FDA's definition for this code reads: "To repair or replace chordae tendinae". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
PAW
Device name
Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement
FDA definition
To repair or replace chordae tendinae.
Regulation
21 CFR 870.3470
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
1

Clearances, product code PAW

By decision year
3 clearances under product code PAW with a decision year between 2012 and 2025, 2012 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PAW by decision year
YearClearances
20121
20141
20251

Applicants with the most clearances

Product code PAW
Applicants holding the most 510(k) clearances under product code PAW
ApplicantClearances
Chawla Heart Technologies, LLC1
On-X Life Technologies Inc.1
On-Xlifetechnologies1

Companies listing this code with FDA

Companies whose registered establishments list this code