Cardiopulmonary Bypass Catheter Kit
Cardiovascular · 21 CFR 870.4210
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.
Recent MDR events
1 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
3 recall events for this product code
- Medtronic Cardiovascular Revascularization & Surgical TherapTerminatedJul 13, 2009
Medtronic One Source Pack, Catalog Numbers: ATLS21, ATLS24, ATLS2469, EC1S24, EC2S00, EC2S24, EE1S048 and EE2S21.
Medtronic has identified a small number of One Source Kits and MAXPAC/Total System lots with incorrect Use Before Dates on the outer kit package label. The Use Before Date on the outer label of the kit/pack does not accurately reflect the Use Before Date of the components within the kit/pack. For affected product, the outer label lists a date which exceeds the earliest Use Before Date of the com
Z-1550-2009 · View FDA record ↗ - Medtronic Cardiovascular Revascularization & Surgical TherapTerminatedJul 13, 2009
Medtronic One Source Pack Magellan, Catalog Number: COS310.
Medtronic has identified a small number of One Source Kits and MAXPAC/Total System lots with incorrect Use Before Dates on the outer kit package label. The Use Before Date on the outer label of the kit/pack does not accurately reflect the Use Before Date of the components within the kit/pack. For affected product, the outer label lists a date which exceeds the earliest Use Before Date of the com
Z-1551-2009 · View FDA record ↗ - Medtronic Cardiovascular Revascularization & Surgical TherapTerminatedJul 13, 2009
Medtronic Ideal MAXPAC Total System, Catalog Numbers: TS1262R6, TS1262R7, TS1420R, TS1420R1, TS1442R, TS1446R, TS1464T, TS1470R, TS1470T1, TS1480R3, TS1480R5, T
Medtronic has identified a small number of One Source Kits and MAXPAC/Total System lots with incorrect Use Before Dates on the outer kit package label. The Use Before Date on the outer label of the kit/pack does not accurately reflect the Use Before Date of the components within the kit/pack. For affected product, the outer label lists a date which exceeds the earliest Use Before Date of the com
Z-1552-2009 · View FDA record ↗
Registered firms
7 firms currently registered for this product code
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.