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

Short-Term Intravascular Filter Catheter

21 CFR 870.3375 / Cardiovascular
FDA source (opens on fda.gov)

PNS is the FDA product code for Short-Term Intravascular Filter Catheter, a class II device type, regulated under 21 CFR 870.3375. FDA's definition for this code reads: "For short-term prevention of pulmonary embolism (PE)". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
PNS
Device name
Short-Term Intravascular Filter Catheter
FDA definition
For short-term prevention of pulmonary embolism (PE)
Regulation
21 CFR 870.3375
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code PNS

By decision year
1 clearance under product code PNS with a decision year between 2016 and 2016, 2016 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PNS by decision year
YearClearances
20161

Applicants with the most clearances

Product code PNS
Applicants holding the most 510(k) clearances under product code PNS
ApplicantClearances
Bio2 Medical, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code