CG FUTURE ANNULOPLASTY SYSTEM, MODEL 638R

Ring, Annuloplasty

MEDTRONIC VASCULAR

The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Cg Future Annuloplasty System, Model 638r.

Pre-market Notification Details

• Device ID: K061127
• 510k Number: K061127
• Device Name: CG FUTURE ANNULOPLASTY SYSTEM, MODEL 638R
• Classification: Ring, Annuloplasty
• Applicant: MEDTRONIC VASCULAR 8299 CENTRAL AVENUE N.E. Minneapolis, MN 55432
• Contact: Phil Neururer
• Correspondent: Phil Neururer; MEDTRONIC VASCULAR 8299 CENTRAL AVENUE N.E. Minneapolis, MN 55432
• Product Code: KRH
• CFR Regulation Number: 870.3800 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-04-24
• Decision Date: 2006-05-23
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00613994758736	K061127	000
00613994521057	K061127	000
00613994521040	K061127	000
00613994521033	K061127	000
00613994521026	K061127	000
00613994521002	K061127	000
00643169793576	K061127	000
00643169793569	K061127	000
00643169793552	K061127	000
00643169793545	K061127	000
00643169793538	K061127	000
00643169793521	K061127	000
00643169793514	K061127	000
00613994751676	K061127	000
00613994751683	K061127	000
00613994751690	K061127	000
00613994758712	K061127	000
00613994758699	K061127	000
00613994758675	K061127	000
00613994758651	K061127	000
00613994758637	K061127	000
00613994758613	K061127	000
00613994758590	K061127	000
00613994751744	K061127	000
00613994751737	K061127	000
00613994751720	K061127	000
00613994751713	K061127	000
00613994751706	K061127	000
00643169793507	K061127	000