Cardiopulmonary Bypass Catheter Kit
FDA product code OEU · Class II (moderate risk) · 21 CFR 870.4210 · Cardiovascular
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
0510(k) clearances
0PMA approvals
3recalls
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1552-2009 | Medtronic Ideal MAXPAC Total System, Catalog Numbers: TS1262R6, TS1262R7, TS1420R…Medtronic has identified a small number of One Source Kits and MAXPAC/Total System lots with incorrect Use… | Medtronic Cardiovascular Revascularization… | 03/23/2009Terminated |
| Z-1551-2009 | Medtronic One Source Pack Magellan, Catalog Number: COS310. Kits are packaging…Medtronic has identified a small number of One Source Kits and MAXPAC/Total System lots with incorrect Use… | Medtronic Cardiovascular Revascularization… | 03/23/2009Terminated |
| Z-1550-2009 | Medtronic One Source Pack, Catalog Numbers: ATLS21, ATLS24, ATLS2469, EC1S24, EC2S00…Medtronic has identified a small number of One Source Kits and MAXPAC/Total System lots with incorrect Use… | Medtronic Cardiovascular Revascularization… | 03/23/2009Terminated |