XENMATRIX SURGICAL GRAFT— 510(k) K140501
Substantially EquivalentC. R. Bard
FDA 510(k) clearance K140501 for XENMATRIX SURGICAL GRAFT, Substantially Equivalent on 2014-04-28. Applicant: C. R. Bard. Device class: 2.
Clearance details
- Applicant
- C. R. Bard
- Product code
- Code FTM
- Device class
- Class 2
- Regulation
- 21 CFR 878.3300
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Warwick, RI, US
Recent devices under product code FTM
view allMore clearances from C. R. Bard
view all- K190527 — GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters
- K182281 — Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech
- K172571 — ULTRASCORE Focused Force PTA Balloon
- K170294 — VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 10cm x 15cm (4x 6) Ellipse, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm (6) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm x 20cm (6x8) Ellipse, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm x 25cm (6x10) Oval
- K162193 — XenMatrix AB Surgical Graft
Adverse events under product code FTM
product code FTM- Death
- 17
- Injury
- 2,174
- Total
- 2,191
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.