T:SLIM (TM) INSULIN DELIVERY SYSTEM— 510(k) K111210
Substantially EquivalentTandem Diabetes Care, Inc.
FDA 510(k) clearance K111210 for T:SLIM (TM) INSULIN DELIVERY SYSTEM, Substantially Equivalent on 2011-11-09. Applicant: Tandem Diabetes Care, Inc.. Device class: 2.
Clearance details
- Applicant
- Tandem Diabetes Care, Inc.
- Product code
- Code LZG
- Device class
- Class 2
- Regulation
- 21 CFR 880.5725
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Recent devices under product code LZG
view allMore clearances from Tandem Diabetes Care, Inc.
view allAdverse events under product code LZG
product code LZG- Death
- 104
- Injury
- 12,022
- Malfunction
- 135,004
- Other
- 1
- Total
- 147,131
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K111210
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K111210.
Data sourced from openFDA. This site is unofficial and independent of the FDA.