VECTOR PTA BALLOON DILATATION CATHETER— 510(k) K131329
Substantially EquivalentR4 Vascular, Inc.
FDA 510(k) clearance K131329 for VECTOR PTA BALLOON DILATATION CATHETER, Substantially Equivalent on 2013-06-06. Applicant: R4 Vascular, Inc.. Device class: 2.
Clearance details
- Applicant
- R4 Vascular, Inc.
- Product code
- Code LIT
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Eagan, MN, US
Recent devices under product code LIT
view allMore clearances from R4 Vascular, Inc.
view all- K121385 — VECTOR
- K100169 — DURASPAN HEMODIALYSIS LONG-TERM CATHETER
- K091506 — DURASPAN HEMODIALYSIS LONG-TERM CATHETER, MODELS 62152420, 621512820, 62153220, 62153620, 62154020, 62155520
- K092040 — PHEROCIOUS 10.5 FR (24 CM, 28 CM AND 32 CM), MODELS 430102440, 430102840, 430103240
- K083763 — ZEUS CT PICC 4 FR AND 5 FR SINGLE AND DUAL LUMEN
Adverse events under product code LIT
product code LIT- Death
- 27
- Injury
- 1,256
- Malfunction
- 12,127
- Total
- 13,410
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.