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FDA 510(k)

BETATRANS I AND II

K-Number: K951592 · 1996-03-04

ApplicantDuxbury Scientific, Inc.
Decision Date1996-03-04
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BETATRANS I AND II 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 1996-03-04 under 510(k) number K951592. 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 I AND II?

BETATRANS I AND II is a medical device that received FDA 510(k) clearance on 1996-03-04. The listed applicant is Duxbury Scientific, Inc.. The 510(k) number is K951592.

When did BETATRANS I AND II receive FDA 510(k) clearance?

BETATRANS I AND II received FDA 510(k) clearance on 1996-03-04, under 510(k) number K951592.

Who is the listed applicant for BETATRANS I AND II?

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 I AND II?

The FDA product code for BETATRANS I AND II is CAC.

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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.

K982241BETATRANS INTRAOP I AND II MODEL NUMBERS DS100X AND DS10XX

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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