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510(k) Data Aggregation
K Number
K992424Device Name
SELDIFLEX LONG-TERM CENTRAL VENOUS CATHETER(40CM & 60CM IN LENGTH), MODELS 63244J20 & 63246J20
Manufacturer
Date Cleared
2000-12-29
(527 days)
Regulation Number
880.5970Why did this record match?
Applicant Name (Manufacturer) :
PLASTIMED LABORATOIRE PHARMACEUTIQUE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Plastimed's Seldiflex® central venous catheter is intended for long-term vascular access and is indicated for use with patients who require central venous pressure monitoring, I.V. fluids, blood products, drugs, or parenteral nutrition solutions.
Device Description
The Seldiflex® is a single lumen, radiopaque polyurethane, long-term central venous catheter. Its accessories include a protective adapter female cap, introducer needle, needle obturator, double-ended J guidewire, scalpel, catheter clamp, rigid fastener, a vessel dilator, and silver Dacron® cuff.
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K Number
K974642Device Name
COMBICATH CATHETER
Manufacturer
Date Cleared
1998-03-13
(88 days)
Regulation Number
874.4680Why did this record match?
Applicant Name (Manufacturer) :
PLASTIMED LABORATOIRE PHARMACEUTIQUE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The COMBICATH Catheter Model 58216.27 is intended for use as a sampling tool by performing mini bronchoalvestar lavage in mechanically ventilated patients to obtain bronchoalveolar samples for laboratory testing and diagnosis.
The COMBICATH Catheter Models 58223.19, 58228.19, and 58229.19 are intended for use as sampling tools to capture protected distal bronchoalveolar samples from mechanically ventilated patients for laboratory testing and diagnosis.
Device Description
The COMBICATH Catheter, is a radiopaque, double plugged, telescoping catheter designed to capture bronchoalveolar secretion samples in mechanically ventilated patients.
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