Central Venous Catheter
510(k) K003839
Central Venous Catheter is a Class II device made by Boston Scientific, cleared under FDA 510(k) K003839 on 1 Aug 2001, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK003839 | Date1 Aug 2001 | StatusActive |
Official records
- FDA 510(k) database K003839
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LJS
- FDA applicant
- Boston Scientific Corp
- Device class
- Class II
- Regulation
- 21 CFR Part 880.5970
- Advisory committee
- General Hospital
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days).
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- VPS Rhythm Device with TipTracker Technology by Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
- ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER SINGLE LUMEN, ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER DUAL LUMEN by Covidien llc
- VAXCEL PICC WITH PASV VALVE TECHNOLOGY by Catheter Innovations, Inc.
- HR POLYURETHANE PICC AND MIDLINE CATHETERS by Johnson & Johnson Medical, Inc.
- PERIPHERALLY INSERTED CENTRAL CATHETER by B. Braun Medical, Inc.
- POWERPICC by Bard Access Systems, Inc.