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FDA 510(k)

AUTOLOGOUS BLOOD MANAGEMENT SYSTEM (ABMS)

K-Number: K982650 · 1998-12-16

ApplicantDideco S.P.A.
Decision Date1998-12-16
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AUTOLOGOUS BLOOD MANAGEMENT SYSTEM (ABMS) is the device name listed in this FDA 510(k) record. The listed applicant is Dideco S.P.A.. It received FDA 510(k) clearance on 1998-12-16 under 510(k) number K982650. 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 AUTOLOGOUS BLOOD MANAGEMENT SYSTEM (ABMS)?

AUTOLOGOUS BLOOD MANAGEMENT SYSTEM (ABMS) is a medical device that received FDA 510(k) clearance on 1998-12-16. The listed applicant is Dideco S.P.A.. The 510(k) number is K982650.

When did AUTOLOGOUS BLOOD MANAGEMENT SYSTEM (ABMS) receive FDA 510(k) clearance?

AUTOLOGOUS BLOOD MANAGEMENT SYSTEM (ABMS) received FDA 510(k) clearance on 1998-12-16, under 510(k) number K982650.

Who is the listed applicant for AUTOLOGOUS BLOOD MANAGEMENT SYSTEM (ABMS)?

The FDA 510(k) record lists Dideco S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUTOLOGOUS BLOOD MANAGEMENT SYSTEM (ABMS)?

The FDA product code for AUTOLOGOUS BLOOD MANAGEMENT SYSTEM (ABMS) is CAC.

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Other records listing Dideco S.P.A. as applicant

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.

K041061D731 MICRO 20 AND D733 MICRO 40 PEDIATRIC ARTERIAL FILTERSK033323D 903 AVANT ADULT HOLLOW FIBER OXYGENATOR AND D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR WITH COATINGK033987D735 MICRO 20 AND D736 MICRO 40 NEWBORN-INFANT ARTERIAL FILTERSK033714MVR 1200 PC: SORIN MONOLYTH VENOUS RESERVOIR 1200 PC WITH PHOSPHORYLCHOLINE COATINGK032040IDEAL MIMESYS SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATORK031223SYNTHESIS MIMESYS ADULT MEMBRANE OXYGENATOR

View all 22 devices →

Related Devices (Code: CAC)

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.

K241236XTRA Collection sets; XTRA Sequestration set XSorin Group Italia S.R.L.K240426Aventus Clot Management SystemInquis MedicalK240584XTRA 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.

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