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

Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures

21 CFR 870.1251 / Cardiovascular
FDA source (opens on fda.gov)

PUM is the FDA product code for Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures, a class II device type, regulated under 21 CFR 870.1251. FDA's definition for this code reads: "Embolic protection for transcatheter intracardiac procedures". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PUM
Device name
Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures
FDA definition
Embolic protection for transcatheter intracardiac procedures
Regulation
21 CFR 870.1251
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
0

Clearances, product code PUM

By decision year
3 clearances under product code PUM with a decision year between 2017 and 2026, 2017 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PUM by decision year
YearClearances
20171
20201
20261

Applicants with the most clearances

Product code PUM
Applicants holding the most 510(k) clearances under product code PUM
ApplicantClearances
Boston Scientific Corporation1
Claret Medical, Inc.1
Emboline, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code