Atlas FDA

POSSIS MEDICAL MYOPORE BIPOLAR SUTURELESS MYCARDIA

FDA 510(k) clearance K925099 · decided 1993-06-22

Clearance details

K-number
K925099
Device name
POSSIS MEDICAL MYOPORE BIPOLAR SUTURELESS MYCARDIA
Applicant
Possis Medical, Inc.
Decision
Substantially Equivalent
Date received
1992-10-08
Decision date
1993-06-22
Days to decision
257 days
Clearance type
Traditional
Product code
DTB
Device class
3
Regulation number
870.3680
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Minneapolis, MN, US
Third-party review
No
Expedited review
No

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Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
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Recalls involving this device

RecordFirmDate
Enpath Myopore Sutureless Myocardial Pacing Lead, Ref: 511211. the contents of the inner p recall (Z-0581-2010)Greatbatch Medical2009-12-29

PMA approvals by this applicant

RecordFirmDate
POSSIS PERMA-SEAL DIALYSIS ACCESS GRAFT (P980017/S001)Possis Medical, Inc.1999-03-24
PERMA-SEAL DIALYSIS ACCESS GRAFT MODEL 2C20 (P980017)Possis Medical, Inc.1998-09-25