CORONARY ARTERY PERFUSION CANNULA WITH SELF-INFLATING BALLOON— 510(k) K030231
Substantially EquivalentSorin Group Italia S.R.L.
FDA 510(k) clearance K030231 for CORONARY ARTERY PERFUSION CANNULA WITH SELF-INFLATING BALLOON, Substantially Equivalent on 2003-04-18. Applicant: Sorin Group Italia S.R.L.. Device class: 2.
Clearance details
- Applicant
- Sorin Group Italia S.R.L.
- Product code
- Code DWF
- Device class
- Class 2
- Regulation
- 21 CFR 870.4210
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mirandola, IT
Recent devices under product code DWF
view allMore clearances from Sorin Group Italia S.R.L.
view all- K251783 — Inspire HCR and HCR DUAL cardiotomy reservoirs
- K253616 — ProtekDilate Vascular Access Kit
- K250610 — Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)
- K250150 — VANGUARD Blood cardioplegia Systems (3 models)
- K243264 — DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14)
Adverse events under product code DWF
product code DWF- Death
- 106
- Injury
- 386
- Malfunction
- 2,323
- Total
- 2,815
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 →
Recalls naming K030231
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K030231.
Data sourced from openFDA. This site is unofficial and independent of the FDA.