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FDA 510(k)

DAVOL POST-OP AUTOTRANSFUSION SYSTEM

K-Number: K913684 · 1991-11-15

ApplicantDavol, Inc.
Decision Date1991-11-15
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DAVOL POST-OP AUTOTRANSFUSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Davol, Inc.. It received FDA 510(k) clearance on 1991-11-15 under 510(k) number K913684. 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 POST-OP AUTOTRANSFUSION SYSTEM?

DAVOL POST-OP AUTOTRANSFUSION SYSTEM is a medical device that received FDA 510(k) clearance on 1991-11-15. The listed applicant is Davol, Inc.. The 510(k) number is K913684.

When did DAVOL POST-OP AUTOTRANSFUSION SYSTEM receive FDA 510(k) clearance?

DAVOL POST-OP AUTOTRANSFUSION SYSTEM received FDA 510(k) clearance on 1991-11-15, under 510(k) number K913684.

Who is the listed applicant for DAVOL POST-OP AUTOTRANSFUSION SYSTEM?

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 POST-OP AUTOTRANSFUSION SYSTEM?

The FDA product code for DAVOL POST-OP AUTOTRANSFUSION SYSTEM 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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