Submission Details
| 510(k) Number | K980600 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 17, 1998 |
| Decision Date | August 12, 1998 |
| Days to Decision | 176 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
D903 AVANT ADULT HOLLOW FIBER OXYGENATOR
Aug 1998
Decision
176d
Days
Class 2
Risk
About This 510(k) Submission
K980600 is an FDA 510(k) clearance for the D903 AVANT ADULT HOLLOW FIBER OXYGENATOR, a Sleeve, Limb, Compressible (Class II — Special Controls, product code JOW), submitted by Dideco S.P.A. (North Attleboro, US). The FDA issued a Cleared decision on August 12, 1998, 176 days after receiving the submission on February 17, 1998. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5800.
Device Classification
| Product Code | JOW — Sleeve, Limb, Compressible |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.5800 |
Manufacturer
Similar Devices — JOW Sleeve, Limb, Compressible
All 348
K254267 · Mego Afek , Ltd.
· Feb 2026
K250974 · Bio Compression Systems, Inc.
· Dec 2025
K250190 · Shenzhen Comen Medical Instruments Co.,Ltd
· Dec 2025
K251466 · Wellell, Inc.
· Oct 2025
K251446 · Manamed, LLC
· Sep 2025
K251086 · Biotab, LLC
· Aug 2025
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