FDA 510(k)

DIDECO COMPACT-A AND COMPACT-M AUTOTRANSFUSION SYSTEMS

K-Number: K963759 · 1998-02-20

Decision Date1998-02-20

Product CodeCAC

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

DIDECO COMPACT-A AND COMPACT-M AUTOTRANSFUSION SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Sorin Biomedical, Inc.. It received FDA 510(k) clearance on 1998-02-20 under 510(k) number K963759. The device is classified under product code CAC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIDECO COMPACT-A AND COMPACT-M AUTOTRANSFUSION SYSTEMS?

DIDECO COMPACT-A AND COMPACT-M AUTOTRANSFUSION SYSTEMS is a medical device that received FDA 510(k) clearance on 1998-02-20. The listed applicant is Sorin Biomedical, Inc.. The 510(k) number is K963759.

When did DIDECO COMPACT-A AND COMPACT-M AUTOTRANSFUSION SYSTEMS receive FDA 510(k) clearance?

DIDECO COMPACT-A AND COMPACT-M AUTOTRANSFUSION SYSTEMS received FDA 510(k) clearance on 1998-02-20, under 510(k) number K963759.

Who is the listed applicant for DIDECO COMPACT-A AND COMPACT-M AUTOTRANSFUSION SYSTEMS?

The FDA 510(k) record lists Sorin Biomedical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIDECO COMPACT-A AND COMPACT-M AUTOTRANSFUSION SYSTEMS?

The FDA product code for DIDECO COMPACT-A AND COMPACT-M AUTOTRANSFUSION SYSTEMS is CAC.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Sorin Biomedical, Inc. as applicant

K990103MONOLYTH C 600 AND 1200 HOLLOW FIBER MEMBRANE LUNG WITH INTEGRATED SOFTSHELL VENOUS RESERVOIR , CVR 600 AND 1200 SOFTSHE K963758CODE 150 BLOOD COMPONENT COLLECTION SET AND WITH DIRECT DRAW LINE K964908VRF40 VENOUS RESERVOIR WITH INTEGRAL CARDIOTOMY FILTER K964907VENOMIDICARD PEDIATRIC VENOUS RESERVOIR WITH INTEGRALCARDIOTOMY FILTER/MIDICARD PEDIATRIC CARDIOTOMY RESERVOIR WITH FILT K961869DIDECO NEWBORN/INFANT ARTERIAL FILTERS: D735 MICRO 20 AND D736 MICRO 40 K952270DIDECO ADULT ARTERIAL FILTERS D732 MICRO 20 W/20, D734 MICRO 40 W/40 MICRON SCREEN

View all 15 devices →

Related Devices (Code: CAC)

K241236XTRA Collection sets; XTRA Sequestration set XSorin Group Italia S.R.L.K240426Aventus Clot Management SystemInquis Medical K240584XTRA Autotransfusion System (with XTRA Bowl sets)Sorin Group Italia S.R.L.K231782FlowSaver Blood Return System (80-101)Inari Medical, Inc.K221483FlowSaver Blood Return SystemInari Medical, Inc.K221722Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)Haemonetics Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.