Atlas FDA

VETA PERITONEAL DIALYSIS CATHETER

FDA 510(k) clearance K113354 · decided 2012-03-13

Clearance details

K-number
K113354
Device name
VETA PERITONEAL DIALYSIS CATHETER
Applicant
Pfm Medical, Inc.
Decision
Unknown
Date received
2011-11-14
Decision date
2012-03-13
Days to decision
120 days
Clearance type
Traditional
Product code
FJS
Device class
2
Regulation number
876.5630
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Carlsbad, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
ASEPT 2000 ml Drainage Bag, Ref No. 622280 Product Usage: The ASEPT Drainage Bag is to be recall (Z-0568-2015)Pfm Medical Inc2014-12-12

PMA approvals by this applicant

RecordFirmDate
NIT-OCCLUD PDA (P120009/S004)Pfm Medical, Inc.2024-10-17
PMA NIT-OCCLUD PDA (P120009/S003)Pfm Medical, Inc.2016-12-16
NIT-OCCLUD SYSTEM (P120009/S002)Pfm Medical, Inc.2015-01-21
NIT-OCCLUD PDA (P120009/S001)Pfm Medical, Inc.2014-08-01
NIT-OCCLUD PDA (P120009)Pfm Medical, Inc.2013-08-16