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

Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling

21 CFR 876.5630 / Gastroenterology, Urology
FDA source (opens on fda.gov)

PNG is the FDA product code for Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling, a class II device type, regulated under 21 CFR 876.5630. FDA's definition for this code reads: "For drainage of refractory ascites with long-term occurrence from the peritoneal cavity". As of , FDA records hold 15 510(k) clearances under this code, the most recent dated , and 13 recalls.

Classification record

Product code
PNG
Device name
Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling
FDA definition
For drainage of refractory ascites with long-term occurrence from the peritoneal cavity.
Regulation
21 CFR 876.5630
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
15
Ingested recalls
13

Clearances, product code PNG

By decision year
15 clearances under product code PNG with a decision year between 2005 and 2025, 2016 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code PNG by decision year
YearClearances
20051
20081
20101
20111
20122
20163
20201
20211
20232
20241
20251

Applicants with the most clearances

Product code PNG
Applicants holding the most 510(k) clearances under product code PNG
ApplicantClearances
Care Fusion4
PFM Medical GmbH3
C.R. Bard Inc2
Rocket Medical2
Bard Peripheral Vascular Inc1
Bearpac Medical, LLC1
Denver Biomedical, Inc.1
Merit Medical Systems, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 26 companies shown, in name order