CARDIOPLEGIA ADAPTERS, VESSEL CANULAE, AND AORTIC ROOT CANNULAE— 510(k) K972503
Substantially EquivalentSorin Group Italia S.R.L.
FDA 510(k) clearance K972503 for CARDIOPLEGIA ADAPTERS, VESSEL CANULAE, AND AORTIC ROOT CANNULAE, Substantially Equivalent on 1997-08-26. 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 K972503
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 K972503.
Data sourced from openFDA. This site is unofficial and independent of the FDA.