SAFEFLO VENA CAVA FILTER— 510(k) K081138
UnknownRmt Medical Technilogies, Inc.
FDA 510(k) clearance K081138 for SAFEFLO VENA CAVA FILTER, Unknown on 2009-05-07. Applicant: Rmt Medical Technilogies, Inc.. Device class: 2.
Clearance details
- Applicant
- Rmt Medical Technilogies, Inc.
- Product code
- Code DTK
- Device class
- Class 2
- Regulation
- 21 CFR 870.3375
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Traditional
- Location
- Philadelphia, PA, US
Recent devices under product code DTK
view all- K242612 — Option ELITE Vena Cava Filter System (352506070E 352506100E)
- K240578 — VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System
- K241507 — ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK)
- K240257 — Denali Vena Cava Filter System Femoral and Jugular/Subclavian Delivery Kit
- K233680 — Celect Platinum Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-CELECT-PT) +4 more
Adverse events under product code DTK
product code DTK- Death
- 208
- Injury
- 11,286
- Malfunction
- 3,002
- Total
- 14,496
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.