Submission Details
| 510(k) Number | K992599 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 03, 1999 |
| Decision Date | November 01, 1999 |
| Days to Decision | 90 days |
| Submission Type | Abbreviated |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Abbreviated
DIDECO ATS AUTOTRANSFUSION CARDIOTOMY RESERVOIR
Nov 1999
Decision
90d
Days
Class 2
Risk
About This 510(k) Submission
K992599 is an FDA 510(k) clearance for the DIDECO ATS AUTOTRANSFUSION CARDIOTOMY RESERVOIR, a Reservoir, Blood, Cardiopulmonary Bypass (Class II — Special Controls, product code DTN), submitted by Dideco S.P.A. (North Attleboro, US). The FDA issued a Cleared decision on November 1, 1999, 90 days after receiving the submission on August 3, 1999. 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
Similar Devices — DTN Reservoir, Blood, Cardiopulmonary Bypass
All 168
K251783 · Sorin Group Italia S.R.L.
· Dec 2025
K241206 · Spectrum Medical S.R.L.
· Jul 2024
K241053 · Medtronic Cardiac Surgery
· May 2024
K223361 · Sorin Group Italia S.R.L.
· Jun 2023
K170583 · Medtronic, Inc.
· Mar 2017
K161733 · Sorin Group Italia S.R.L.
· Mar 2017
More from Dideco S.P.A.
View all
K041061
· DTM · May 2004
K033323
· DTZ · Jan 2004
K033987
· DTM · Jan 2004
K033714
· DTN · Dec 2003
K032040
· KFM · Jul 2003