CARDIOPULMONARY BYPASS VASCULAR CATHETER— 510(k) K905224
Substantially Equivalent3M Health Care, Sarns
FDA 510(k) clearance K905224 for CARDIOPULMONARY BYPASS VASCULAR CATHETER, Substantially Equivalent on 1991-02-05. Applicant: 3M Health Care, Sarns. Device class: 2.
Clearance details
- Applicant
- 3M Health Care, Sarns
- 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
- Ann Arbor, MI, US
Recent devices under product code DWF
view allMore clearances from 3M Health Care, Sarns
view allAdverse 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 K905224
K-number listed on FDA's recall record- Z-2097-2014 — Sarns Malleable Venous Return Cannulae 24, 28, 30, 32, 34, 36 & 40 Fr single stage with 3/8" & 1/2 flare with or without Xcoating Product Usage: The Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava.
- Z-2106-2014 — CPB Catheter Kit Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K905224.
Data sourced from openFDA. This site is unofficial and independent of the FDA.