K141758 is an FDA 510(k) clearance for the T:SLIM INSULIN DELIVERY SYSTEM. This device is classified as a Pump, Infusion, Insulin (Class II - Special Controls, product code LZG).
Submitted by Tandem Diabetes Care, Inc. (Philedelphia, US). The FDA issued a Cleared decision on October 31, 2014, 123 days after receiving the submission on June 30, 2014.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K141758 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 30, 2014 |
| Decision Date | October 31, 2014 |
| Days to Decision | 123 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LZG — Pump, Infusion, Insulin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |