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FDA 510(k)

DAVOL CARDIOVASCULAR AUTOTRANSFUSION UNIT

K-Number: K931552 · 1993-10-08

ApplicantDavol, Inc.
Decision Date1993-10-08
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DAVOL CARDIOVASCULAR AUTOTRANSFUSION UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Davol, Inc.. It received FDA 510(k) clearance on 1993-10-08 under 510(k) number K931552. 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 DAVOL CARDIOVASCULAR AUTOTRANSFUSION UNIT?

DAVOL CARDIOVASCULAR AUTOTRANSFUSION UNIT is a medical device that received FDA 510(k) clearance on 1993-10-08. The listed applicant is Davol, Inc.. The 510(k) number is K931552.

When did DAVOL CARDIOVASCULAR AUTOTRANSFUSION UNIT receive FDA 510(k) clearance?

DAVOL CARDIOVASCULAR AUTOTRANSFUSION UNIT received FDA 510(k) clearance on 1993-10-08, under 510(k) number K931552.

Who is the listed applicant for DAVOL CARDIOVASCULAR AUTOTRANSFUSION UNIT?

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

What is the FDA product code for DAVOL CARDIOVASCULAR AUTOTRANSFUSION UNIT?

The FDA product code for DAVOL CARDIOVASCULAR AUTOTRANSFUSION UNIT is CAC.

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Other records listing Davol, 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.

K251557Bard® Mesh; Bard® Mesh Pre-ShapedK250098Bard Soft Mesh; Bard Soft Mesh Pre-ShapedK031213AQUASENS FLUID MONITORING SYSTEMK030307DAVOL ARTHROVENT OUTFLOW TUBINGK003323COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205K003790DAVOL X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM, MODELS 5551000, 5552000, 5552001, 552002, 5552003, 5552004, 5552005

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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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