Biodesign Diaphragmatic Hernia Graft— 510(k) K171817
Substantially EquivalentCook Biotech Incorporated
FDA 510(k) clearance K171817 for Biodesign Diaphragmatic Hernia Graft, Substantially Equivalent on 2018-03-13. Applicant: Cook Biotech Incorporated. Device class: 2.
Clearance details
- Applicant
- Cook Biotech Incorporated
- 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
- Traditional
- Location
- West Lafayette, IN, US
Recent devices under product code FTM
view allMore clearances from Cook Biotech Incorporated
view all- K232646 — Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9)
- K201000 — Biodesign Staple Line Reinforcement
- K191696 — Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft
- K162934 — Biodesign Parastomal Hernia Repair Graft
- K170016 — Biodesign Fistula Plug
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.