PFM Medical, Inc

Registration Details

Registration Name: PFM Medical, Inc
Registration Number: 3013666218
FEI Number: 3013666218
Status: Active
Expiry Year: 2026
Initial Importer: Yes
Address: 1916 Palomar Oaks Way, Suite 150
City: Carlsbad
State: CA
ZIP: 92008
Country: US

Regulatory Submissions

510(k) Number: K000125
PMA Number: P120009

Owner / Operator

Firm Name: PFM MEDICAL, INC
Operator Number: 9052164
Address: 1916 Palomar Oaks Way, Suite 150
City: Carlsbad
State: CA
Postal Code: 92008
Country: US
Correspondent: Jiaye Jho

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Port & Catheter, Implanted, Subcutaneous, Intravascular	LJT	Class 2	General Hospital	No	2002-07-18
Kit, Surgical Instrument, Disposable	KDD	Class 1	General, Plastic Surgery	No	2020-08-28
Bronchoscope (Flexible Or Rigid)	EOQ	Class 2	Ear, Nose, Throat	No	2021-07-27
Microtome, Accessories	IDL	Class 1	Pathology	No	2011-01-08
Midline Catheter	PND	Class 2	General Hospital	No	2018-03-19
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	LJS	Class 2	General Hospital	No	2008-01-04
Catheter, Embolectomy	DXE	Class 2	Cardiovascular	No	2002-07-18
Occluder, Patent Ductus, Arteriosus	MAE	Class 3	Unknown	No	2014-01-02
Bottle, Collection, Vacuum	KDQ	Class 2	General Hospital	No	2013-05-10
Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling	PNG	Class 2	Gastroenterology, Urology	No	2023-05-23
Accessories, Catheter	KGZ	Class 1	General, Plastic Surgery	No	2020-02-21
Microtome, Sliding	KFL	Class 1	Pathology	No	2011-01-08
Stylet, Surgical, General & Plastic Surgery	GAH	Class 1	General, Plastic Surgery	No	2017-09-21
Fluid Drainage Tray	PXU	Class 1	General, Plastic Surgery	No	2018-01-23
Peritoneal Dialysis Administration Kit	PPJ	Class 2	Gastroenterology, Urology	No	2017-12-14
Container, Specimen, Sterile	FMH	Class 1	Pathology	No	2012-06-18
Bath, Incubators/Water, All	JTQ	Class 1	Microbiology	No	2011-01-08
Device, Biopsy, Endomyocardial	DWZ	Class 2	Cardiovascular	No	2021-07-27
Needle, Catheter	GCB	Class 1	General, Plastic Surgery	No	2011-06-03
Apparatus, Suction, Patient Care	DWM	Class 2	Cardiovascular	No	2009-11-17
Catheter Introducer Kit	OFC	Class 2	Cardiovascular	No	2017-01-26
Apparatus, Suction, Ward Use, Portable, Ac-Powered	JCX	Class 2	General, Plastic Surgery	No	2002-07-18
Microtome, Rotary	IDO	Class 1	Pathology	No	2011-01-08
Mesh, Surgical	FTM	Class 2	General, Plastic Surgery	No	2019-06-21
Forceps	HTD	Class 1	General, Plastic Surgery	No	2010-05-19
Vascular Access Port Kit	PXK	Class 2	General Hospital	No	2020-07-29
Minor Surgical Procedures Tray	PYB	Class 1	General, Plastic Surgery	No	2018-11-14
Catheter, Peritoneal, Long-Term Indwelling	FJS	Class 2	Gastroenterology, Urology	No	2012-07-11

Proprietary Names

JET PORT PLUS CATHETER SYSTEM T-Port HP Infusion Port PFM Various Microtome Accessories Tita Jet Light HP Catheter System Jet Port Plus HP Catheter System primeMidline PFM PICC primePICC MULTI-SNARE SET Jet-Vac Asept ASEPT PFM Sliding Microtome Stylet Veta Peritoneal Dialysis Insertion Kit Asept Drainage Bag PFM Water Bath Rapid Centesis Catheter pfm Microintroducer Kit Asept Peritoneal Drainage System T-Port HP Catheter System REDON SET TiMESH NeedleDok Jet Port Tita Jet Triple Lumen PFM PICC PFM PICC II PFM PICC CT II Veta Peritoneal Dialysis Catheter

Establishment Types

Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)