DAIG COLLAPSIBLE STERILE SLEEVE— 510(k) K884478

Clearance details

Applicant

Daig Corp.

Product code

Code DQR

Device class

Class 2

Regulation

21 CFR 870.1300

Advisory panel

Cardiovascular

Date received

1988-10-25

Decision date

1989-02-22

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Minnetonka, MN, US

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• K973840 — FAST-CATH (TM) INTRA-CARDIAC INTRODUCER1998-05-21

Death

2

Total

2

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 →