K063240 is an FDA 510(k) clearance for the SHERLOCK TLS STYLET, SHERLOCK TLS DETECTOR. This device is classified as a Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (Class II - Special Controls, product code LJS).
Submitted by C.R. Bard, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on November 21, 2006, 26 days after receiving the submission on October 26, 2006.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5970.
| 510(k) Number | K063240 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 26, 2006 |
| Decision Date | November 21, 2006 |
| Days to Decision | 26 days |
| Submission Type | Special |
| 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 |