Atlas FDA

DATASCOPE'S 8FR. POLYMIDE 25CC,34CC AND 40CC IAB AND ACCESSORIES, MODELS 0684-00-0327, 06844-00-0328, 0684-00-0329

FDA 510(k) clearance K994157 · decided 2000-03-13

Clearance details

K-number
K994157
Device name
DATASCOPE'S 8FR. POLYMIDE 25CC,34CC AND 40CC IAB AND ACCESSORIES, MODELS 0684-00-0327, 06844-00-0328, 0684-00-0329
Applicant
Datascope Corp.
Decision
Substantially Equivalent
Date received
1999-12-09
Decision date
2000-03-13
Days to decision
95 days
Clearance type
Traditional
Product code
DSP
Device class
2
Regulation number
870.3535
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Fairfield, NJ, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
ABSORBABLE COLLAGEN HEMOSTAT (P850023/S014)Datascope Corp.1994-12-22
HEMOPAD(TM) ABSORBABLE COLLAGEN HEMOSTAT (P850023/S010)Datascope Corp.1992-11-16
ABSORBABLE COLLAGEN HEMOSTAT (P850023/S013)Datascope Corp.1992-08-26
HEMAFLEX (TM) MED-CHEM PRODUCTS,DISTRIBUTOR (P850023/S011)Datascope Corp.1991-10-04
NOVACOL(TM) TEXTURED COLLAGEN HEMOSTATIC AGENT (P850023/S009)Datascope Corp.1990-09-28
NOVACOL(TM) TEXTURED COLLAGEN HEMOSTATIC AGENT (P850023/S005)Datascope Corp.1989-05-17
NOVACOL(TM) TEXTURED COLLAGEN HEMOSTATIC AGENT (P850023/S008)Datascope Corp.1989-03-09
NOVACOL(TM) TEXTURED COLLAGEN HEMOSTATIC AGENT (P850023/S006)Datascope Corp.1988-09-09