DURAN BAND (MODEL H607H), DURAN RING (MODEL 610R), DURAN BAND (MODEL 610B), DURAN ANCORE RING (MODEL 620R), DURAN ANCORE

Ring, Annuloplasty

MEDTRONIC HEART VALVES

The following data is part of a premarket notification filed by Medtronic Heart Valves with the FDA for Duran Band (model H607h), Duran Ring (model 610r), Duran Band (model 610b), Duran Ancore Ring (model 620r), Duran Ancore.

Pre-market Notification Details

• Device ID: K032810
• 510k Number: K032810
• Device Name: DURAN BAND (MODEL H607H), DURAN RING (MODEL 610R), DURAN BAND (MODEL 610B), DURAN ANCORE RING (MODEL 620R), DURAN ANCORE
• Classification: Ring, Annuloplasty
• Applicant: MEDTRONIC HEART VALVES 8299 CENTRAL AVE., N.E. M.S. P108 Minneapolis, MN 55432 -3576
• Contact: Julie Sherman
• Correspondent: Julie Sherman; MEDTRONIC HEART VALVES 8299 CENTRAL AVE., N.E. M.S. P108 Minneapolis, MN 55432 -3576
• Product Code: KRH
• CFR Regulation Number: 870.3800 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-09-09
• Decision Date: 2003-12-05
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00721902859755	K032810	000
00643169793446	K032810	000
00643169793453	K032810	000
00643169793460	K032810	000
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00613994526960	K032810	000
00613994526977	K032810	000
00613994526984	K032810	000
00613994527028	K032810	000
00613994527059	K032810	000
00643169793439	K032810	000
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00721902859762	K032810	000
00721902859786	K032810	000
00721902859793	K032810	000
00721902859809	K032810	000
00721902859816	K032810	000
00721902859823	K032810	000
00643169793361	K032810	000
00643169793378	K032810	000
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00613994527066	K032810	000
00613994749666	K032810	000
00613994749673	K032810	000
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00613994758965	K032810	000
00613994758989	K032810	000
00613994759009	K032810	000
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00613994759047	K032810	000
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00613994759085	K032810	000
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00613994759122	K032810	000
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00613994758927	K032810	000
00613994758903	K032810	000
00613994749796	K032810	000
00613994749680	K032810	000
00613994749697	K032810	000
00613994749703	K032810	000
00613994749710	K032810	000
00613994749727	K032810	000
00613994749734	K032810	000
00613994749741	K032810	000
00613994749758	K032810	000
00613994749765	K032810	000
00613994749772	K032810	000
00613994749789	K032810	000
00613994759160	K032810	000