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FDA 510(k)

BETATRANS INTRAOP I AND II MODEL NUMBERS DS100X AND DS10XX

K-Number: K982241 · 1998-11-30

ApplicantDuxbury Scientific, Inc.
Decision Date1998-11-30
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BETATRANS INTRAOP I AND II MODEL NUMBERS DS100X AND DS10XX is the device name listed in this FDA 510(k) record. The listed applicant is Duxbury Scientific, Inc.. It received FDA 510(k) clearance on 1998-11-30 under 510(k) number K982241. 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 BETATRANS INTRAOP I AND II MODEL NUMBERS DS100X AND DS10XX?

BETATRANS INTRAOP I AND II MODEL NUMBERS DS100X AND DS10XX is a medical device that received FDA 510(k) clearance on 1998-11-30. The listed applicant is Duxbury Scientific, Inc.. The 510(k) number is K982241.

When did BETATRANS INTRAOP I AND II MODEL NUMBERS DS100X AND DS10XX receive FDA 510(k) clearance?

BETATRANS INTRAOP I AND II MODEL NUMBERS DS100X AND DS10XX received FDA 510(k) clearance on 1998-11-30, under 510(k) number K982241.

Who is the listed applicant for BETATRANS INTRAOP I AND II MODEL NUMBERS DS100X AND DS10XX?

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

What is the FDA product code for BETATRANS INTRAOP I AND II MODEL NUMBERS DS100X AND DS10XX?

The FDA product code for BETATRANS INTRAOP I AND II MODEL NUMBERS DS100X AND DS10XX 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.

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Other records listing Duxbury Scientific, Inc. 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.

K951592BETATRANS I AND II

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

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

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