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510(k) Data Aggregation
K Number
K241278Device Name
ASEPT® Glide Peritoneal Drainage System
Manufacturer
PFM Medical, Inc.
Date Cleared
2025-01-14
(253 days)
Product Code
PNG
Regulation Number
876.5630Why did this record match?
Applicant Name (Manufacturer) :
PFM Medical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ASEPT Glide Peritoneal Drainage System is indicated for intermittent, long-term drainage of symptomatic, recurrent, malignant and non-malignant ascites that does not respond to medical management of the underlying disease and for the palliation of symptoms related to recurrent ascites.
The use of the ASEPT Glide Peritoneal Catheter for non-malignant ascites is limited to patients who are intolerant or resistant to maximum medical therapy, refractory to large volume paracentesis (LVP) and are not candidates for trans-juqular intrahepatic portosystemic shunt or LVP. The ASEPT Glide Peritoneal Catheter is indicated for adults only.
Device Description
The ASEPT Glide Peritoneal Drainage System provides patients with a method to drain accumulated fluid from the abdomen. The primary components of the system are the indwelling ASEPT Glide Peritoneal Catheter and the ASEPT Drainage Kit. The catheter is placed in the patient's peritoneal cavity enabling the patient to perform periodic peritoneal drainage at home or in the hospital. The device is provided sterile.
The ASEPT Glide Peritoneal Drainage Catheter has a surface modification applied from the distal tip to the polyester cuff.
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K Number
K221779Device Name
ASEPT Peritoneal Drainage System
Manufacturer
PFM Medical, Inc.
Date Cleared
2023-05-02
(315 days)
Product Code
PNG
Regulation Number
876.5630Why did this record match?
Applicant Name (Manufacturer) :
PFM Medical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ASEPT Peritoneal Drainage System is indicated for intermittent, long-term drainage of symptomatic, recurrent, malignant and non-malignant ascites that does not respond to medical management of the underlying disease and for the palliation of symptoms related to recurrent ascites.
The use of the ASEPT Peritoneal Catheter for non-malignant ascites is limited to patients who are intolerant or resistant to maximum medical therapy, refractory to large volume paracentesis (LVP) and are not candidates for a trans-jugular intrahepatic portosystemic shunt or LVP. The ASEPT Peritoneal Catheter is indicated for adults only.
Device Description
The ASEPT Peritoneal Drainage System provides patients with a method to drain accumulated fluid from the abdomen. The primary components of the system are the indwelling ASEPT Peritoneal Catheter and the ASEPT Drainage Kit. The catheter is placed in the patient's peritoneal cavity enabling the patient to perform periodic peritoneal drainage at home or in the hospital.
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K Number
K213666Device Name
NuCath Wedge Pressure Catheter
Manufacturer
PFM Medical, Inc.
Date Cleared
2022-10-06
(318 days)
Product Code
DQO
Regulation Number
870.1200Why did this record match?
Applicant Name (Manufacturer) :
PFM Medical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NuCath™ Wedge Pressure Catheter is indicated for measuring pressure in the right heart (including central venous pressure, right ventricle pressure, pulmonary artery pressure, and pulmonary artery wedge pressure).
Device Description
The NuCath Wedge Pressure Catheter is an intravascular catheter with a balloon at the distal tip intended to measure pressure in the right heart.
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K Number
K192802Device Name
primeMidline Catheters
Manufacturer
PFM Medical, Inc.
Date Cleared
2019-10-28
(28 days)
Product Code
PND
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
PFM Medical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The primeMIDLINE™ Catheters are indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling and power injection of contrast media. These catheters are indicated for patients older than 28 days and that weigh more than 10 kg, with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The primeMIDLINE™ Catheters are suitable for use with power injectors.
Device Description
The 4F DL primeMIDLINE™ Catheter is a peripherally placed midline catheter designed to provide access to the vascular system. The catheter lumen is an open-ended design comprised of radiopaque polyurethane. The 4F DL primeMIDLINE ™ Catheter is packaged sterile in a tray with the accessories necessary to establish short-term (less than 30 days) vascular access. The 4F DL primeMIDLINE Catheter is suitable for use with power injectors.
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K Number
K173114Device Name
primeMidline Catheters
Manufacturer
PFM Medical, Inc.
Date Cleared
2018-03-07
(159 days)
Product Code
PND
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
PFM Medical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The primeMIDLINE™ Catheters are indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling and power injection of contrast media. These catheters are indicated for patients older than 28 days and that weigh more than 10kg, with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The primeMIDLINE™ Catheters are suitable for use with power injectors.
Device Description
The primeMIDLINE™ Catheters are a family of peripherally placed midline catheters designed to provide access to the vascular system. These catheters are offered in 3F, 4F and 5F Single Lumen and 5F Dual Lumen configurations with 20cm lengths. The catheter lumen is an open-ended design comprised of radiopaque polyurethane. Each primeMIDLINE™ Catheter is packaged sterile in a tray with the accessories necessary to establish short-term (less than 30 days) vascular access. The primeMIDLINE™ Catheters are suitable for use with power injectors.
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