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Found 2 results

510(k) Data Aggregation

K Number

Device Name

SUTURING WASHER

Manufacturer

FIRST CALL, INC.

Date Cleared

2006-01-17

(113 days)

Product Code

MAB

Regulation Number

870.3450

Why did this record match?

Product Code :

MAB

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

This single use device is for radiological identification of the aortic anastomosis in coronary artery bypass surgery

Device Description

This 4.5mm outer diameter suturing washer is manufactured from either stainless steel (ASTM F-138) or titanium (ASTM F-136). It is permanently implanted and must be sterilized prior to use.

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K Number

Device Name

GRAFT MARKER RING

Manufacturer

T. KOROS SURGICAL INSTRUMENTS CORP.

Date Cleared

2001-04-27

(308 days)

Product Code

MAB

Regulation Number

870.3450

Why did this record match?

Product Code :

MAB

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Device Description

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