BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS— 510(k) K130736
Substantially EquivalentHelix Medical, LLC
FDA 510(k) clearance K130736 for BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS, Substantially Equivalent on 2013-12-17. Applicant: Helix Medical, LLC. Device class: 1.
Clearance details
- Applicant
- Helix Medical, LLC
- Product code
- Code LRC
- Device class
- Class 1
- Regulation
- 21 CFR 874.4420
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carpinteria, CA, US
Recent devices under product code LRC
view allMore clearances from Helix Medical, LLC
view allAdverse events under product code LRC
product code LRC- Death
- 5
- Total
- 5
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.