CCENTERMARK CATHETER INTRODUCER SHEALTH WITH PROTECTIV 2000 NEEDLE SAFETY SYSTEM
Device Facts
| Record ID | K962978 |
|---|---|
| Device Name | CCENTERMARK CATHETER INTRODUCER SHEALTH WITH PROTECTIV 2000 NEEDLE SAFETY SYSTEM |
| Applicant | Johnson & Johnson Medical, Inc. |
| Product Code | DYB · Cardiovascular |
| Decision Date | Jan 7, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1340 |
| Device Class | Class 2 |
Intended Use
The CENTERMARK* Catheter Introducer Sheath with PROTECTIV* 2000 Needle Safety System is designed for percutaneous access for the introduction of catheters and guidewires. The PROTECTIV* 2000 Needle Safety System is designed to reduce needle sticks injuries.
Device Story
Device consists of catheter introducer sheath and integrated needle safety system; used for percutaneous access for catheter/guidewire placement. Safety system mechanism designed to reduce needle stick injuries during procedure. Used by clinicians in clinical settings. Device facilitates vascular or other percutaneous access; safety feature protects operator from sharps injury.
Clinical Evidence
Bench testing only; includes biocompatibility, sterility, and system performance testing.
Technological Characteristics
Catheter introducer sheath; integrated needle safety system. Sterilization method not specified. Materials biocompatible per standard testing.
Indications for Use
Indicated for percutaneous access for the introduction of catheters and guidewires in patients requiring such access.
Regulatory Classification
Identification
A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.
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