Submission Details
| 510(k) Number | K001602 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 24, 2000 |
| Decision Date | June 08, 2000 |
| Days to Decision | 15 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
DIDECO LILLIPUT 1 TWIN RESERVOIR WITH PHOSPHORILCHOLINE INSERT SURFACE IN OXYGENATION (PH. I.S.I.O.)
Jun 2000
Decision
15d
Days
Class 2
Risk
About This 510(k) Submission
K001602 is an FDA 510(k) clearance for the DIDECO LILLIPUT 1 TWIN RESERVOIR WITH PHOSPHORILCHOLINE INSERT SURFACE IN OXYGENATION (PH. I.S.I.O.), a Reservoir, Blood, Cardiopulmonary Bypass (Class II — Special Controls, product code DTN), submitted by Dideco S.P.A. (Waltham, US). The FDA issued a Cleared decision on June 8, 2000, 15 days after receiving the submission on May 24, 2000. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4400.
Device Classification
| Product Code | DTN — Reservoir, Blood, Cardiopulmonary Bypass |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.4400 |
Manufacturer
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