K070002 is an FDA 510(k) clearance for the BOSTON SCIENTIFIC PERIPHERALLY INSERTED CENTRAL CATHETER. This device is classified as a Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (Class II - Special Controls, product code LJS).
Submitted by Boston Scientific (Marlboro, US). The FDA issued a Cleared decision on August 17, 2007, 226 days after receiving the submission on January 3, 2007.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5970.
| 510(k) Number | K070002 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 03, 2007 |
| Decision Date | August 17, 2007 |
| Days to Decision | 226 days |
| Submission Type | Abbreviated |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LJS — Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5970 |