POSTERIOR ANNULOPLASTY BAND (MODEL 607)— 510(k) K960356

Clearance details

Applicant

The Heart Valve Div. Medtronic Cardiovascular Surg

Product code

Code KRH

Device class

Class 2

Regulation

21 CFR 870.3800

Advisory panel

Cardiovascular

Date received

1996-01-25

Decision date

1996-08-27

Decision

Substantially Equivalent - Subject to Tracking Reg.

Clearance type

Traditional

Location

Irvine, CA, US

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Death

45

Injury

2,235

Total

2,280

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →