FDA.reportPublic FDA data

PFM Medical GmbH

Matched from indexed company URL: PFM Medical, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96174653003769549PFM Medical GmbH1N2026-01-01WANKLESTRASSE 60 COLOGNE North Rhine-Westphalia DE 50996
30057048223005704822pfm medical mepro gmbh1N2026-01-01Am Soterberg 4 Nonnweiler-Otzenhausen Saarland DE 66620
30136662183013666218PFM Medical, Inc1Y2026-01-011916 Palomar Oaks Way Suite 150 Carlsbad CA US 92008

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00813623011144ASEPT Peritoneal Drainage System - ASEPT 1,000mL Drainage Kit7607588749regulatory@pfmmedicalusa.com
00813623012066ASEPT - ASEPT 1000mL Drainage Bottle with Y-Site Drain7607588749regulatory@pfmmedicalusa.com
00813623015371ASEPT Peritoneal Drainage System - ASEPT 1,000mL Drainage Kit7607588749regulatory@pfmmedicalusa.com
00813623017016ASEPT Pleural Drainage System - M70017607588749regulatory@pfmmedicalusa.com
00813623017054ASEPT - ASEPT Drainage Line Set7607588749regulatory@pfmmedicalusa.com
04042301159939Nit-Occlud PDA - Nit-Occlud® PDA is a system for transcatheter occlusion of Patent Ductus Arteriosus (PDA) with spiral coils. The system consists of a spiral coil mounted in a straightened fashion on a flexible delivery system including a disposable handle. The Nit-Occlud® PDA has a cone in cone configuration which results from the fact that the proximal windings of the coil are wound the reverse direction. Nit-Occlud® PDA is available as Flexible and Medium Type. The flexible and medium types are pre-loaded into the transportation sheath.7607588749spalomares@pfmmedicalusa.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
181221582944823P120009NIT-OCCLUD PDAMAE2013-08-16
732111582944823P120009NIT-OCCLUD PDAMAE2013-08-16
2087622012567571P120009NIT-OCCLUD PDAMAE2013-08-16
2087621099453173K221779ASEPT Peritoneal Drainage SystemPNG2023-05-02
2087621198653070K173114primeMidline CathetersPND2018-03-07
2087621363327698K122402LPP (LOW PROFILE PORT)LJT2013-07-16
2087621779139157K113354VETA PERITONEAL DIALYSIS CATHETERFJS2012-03-13
2087621832650818K111559SURGICAL MASKSFXX2011-09-16
2087621623557998K110914TRIPLE LUMEN PFM PICCLJS2011-09-21
2087621151633272K093796ASEPT PERITONEAL DRAINAGE SYSTEMPNG2010-02-26
2087621944884662K093307ASEPT PLEURAL DRAINAGE SYSTEMDWM2009-11-06
2087621128173980K083873PICC (CT RATED AND NON-RATED)LJS2009-03-19
2087621564240152K073210MODIFICATION TO: T-PORT HP INFUSION PORTLJT2007-12-12
2087621265855355K072481JET PORT PLUS HP CATHETER SYSTEMLJT2008-03-07
2087621345516611K072391PFM PICCLJS2007-11-19
2087621320460894K071993T-PORT HP INFUSION PORTLJT2007-10-17
181221640699606K031225TIMESH ALSO KNOWN AS TIMESH-TC, MODELS 6000001 & 6000004FTL2003-09-29
2087621902171268K011783MULTI-SNARE SETDXE2002-01-24
732111940157323K011783MULTI-SNARE SETDXE2002-01-24
181221940157323K011783MULTI-SNARE SETDXE2002-01-24
2087621628690360K001716REDON SETJCX2000-07-19
732111834047704K001716REDON SETJCX2000-07-19
181221834047704K001716REDON SETJCX2000-07-19
2087621796321378K000125JET PORT PLUS CATHETER SYSTEMLJT2000-04-12
181221070991704
181221935955240
181222031297115
732111004945538
2087621011652000
2087621016498696
732111017464519
732111070991704
2087621089762475
2087621103294449
181221128243112
2087621128726622
732111135750480
181221135750480
732111136785145
732111169046285
2087621170346492
2087621235322215
732111258977340
732111267408957
2087621333802921
2087621358340921
2087621372133878
2087621388466447
181221401653141
2087621441622006
2087621477389637
181221480116410
732111558316068
732111675195769
2087621707894830
732111709923462
732111717278783
2087621737397206
732111771844984
2087621803121440
2087621822309229
732111848724835
181221859811770
732111935955240
2087621964513569
732112030917690
732112031297115
2087622038600175

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LJT52013-07-16
MAE32013-08-16
LJS32011-09-21
DXE32002-01-24
JCX32000-07-19
PNG22023-05-02
PND12018-03-07
FJS12012-03-13
FXX12011-09-16
DWM12009-11-06
FTL12003-09-29

PMA#

PMN#

GUDID#

Nit-Occlud PDA - Nit-Occlud® PDA is a system for transcatheter occlusion of Patent Ductus Arteriosus (PDA) with spiral coils. The system consists of a spiral coil mounted in a straightened fashion on a flexible delivery system including a disposable handle. The Nit-Occlud® PDA has a cone in cone configuration which results from the fact that the proximal windings of the coil are wound the reverse direction. Nit-Occlud® PDA is available as Flexible and Medium Type. The flexible and medium types are pre-loaded into the transportation sheath.

pfm medical ag

2014-08-06

Nit-Occlud PDA - Nit-Occlud® PDA is a system for transcatheter occlusion of Patent Ductus Arteriosus (PDA) with spiral coils. The system consists of a spiral coil mounted in a straightened fashion on a flexible delivery system including a disposable handle. The Nit-Occlud® PDA has a cone in cone configuration which results from the fact that the proximal windings of the coil are wound the reverse direction. Nit-Occlud® PDA is available as Flexible and Medium Type. The flexible and medium types are pre-loaded into the transportation sheath.

pfm medical ag

2014-08-06

Nit-Occlud PDA - Nit-Occlud® PDA is a system for transcatheter occlusion of Patent Ductus Arteriosus (PDA) with spiral coils. The system consists of a spiral coil mounted in a straightened fashion on a flexible delivery system including a disposable handle. The Nit-Occlud® PDA has a cone in cone configuration which results from the fact that the proximal windings of the coil are wound the reverse direction. Nit-Occlud® PDA is available as Flexible and Medium Type. The flexible and medium types are pre-loaded into the transportation sheath.

pfm medical ag

2014-08-06

Nit-Occlud PDA - Nit-Occlud® PDA is a system for transcatheter occlusion of Patent Ductus Arteriosus (PDA) with spiral coils. The system consists of a spiral coil mounted in a straightened fashion on a flexible delivery system including a disposable handle. The Nit-Occlud® PDA has a cone in cone configuration which results from the fact that the proximal windings of the coil are wound the reverse direction. Nit-Occlud® PDA is available as Flexible and Medium Type. The flexible and medium types are pre-loaded into the transportation sheath.

pfm medical ag

2014-08-06

Nit-Occlud PDA - Nit-Occlud® PDA is a system for transcatheter occlusion of Patent Ductus Arteriosus (PDA) with spiral coils. The system consists of a spiral coil mounted in a straightened fashion on a flexible delivery system including a disposable handle. The Nit-Occlud® PDA has a cone in cone configuration which results from the fact that the proximal windings of the coil are wound the reverse direction. Nit-Occlud® PDA is available as Flexible and Medium Type. The flexible and medium types are pre-loaded into the transportation sheath.

pfm medical ag

2014-08-06

Nit-Occlud PDA - Nit-Occlud® PDA is a system for transcatheter occlusion of Patent Ductus Arteriosus (PDA) with spiral coils. The system consists of a spiral coil mounted in a straightened fashion on a flexible delivery system including a disposable handle. The Nit-Occlud® PDA has a cone in cone configuration which results from the fact that the proximal windings of the coil are wound the reverse direction. Nit-Occlud® PDA is available as Flexible and Medium Type. The flexible and medium types are pre-loaded into the transportation sheath.

pfm medical ag

2014-08-06

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