The following data is part of a premarket notification filed by Lucent Medical Systems with the FDA for Sherlock Tip Location System (tls) Detector And Accessories.
| Device ID | K061240 |
| 510k Number | K061240 |
| Device Name: | SHERLOCK TIP LOCATION SYSTEM (TLS) DETECTOR AND ACCESSORIES |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | LUCENT MEDICAL SYSTEMS 811 KIRKLAND AVENUE; SUITE 100 Kirkland, WA 98033 |
| Contact | Cynthia Pestka |
| Correspondent | Cynthia Pestka LUCENT MEDICAL SYSTEMS 811 KIRKLAND AVENUE; SUITE 100 Kirkland, WA 98033 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-03 |
| Decision Date | 2006-06-02 |
| Summary: | summary |