Atlas FDA

DATASCOPE ARTERIAL CANNULA W/ACCESS PORT

FDA 510(k) clearance K902674 · decided 1991-01-16

Clearance details

K-number
K902674
Device name
DATASCOPE ARTERIAL CANNULA W/ACCESS PORT
Applicant
Datascope Corp.
Decision
Substantially Equivalent
Date received
1990-06-18
Decision date
1991-01-16
Days to decision
212 days
Clearance type
Traditional
Product code
DQR
Device class
2
Regulation number
870.1300
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Oakland, NJ, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

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

RecordFirmDate
INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLES (K131446)Integra LifeSciences Corporation2013-10-28
18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA II (K073559)Edwards Lifesciences Research Medical2008-01-31
ANGIODYNAMICS, INC., MICRO ACCESS KITS (K051655)AngioDynamics, Inc.2005-09-12
CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-6221 (K030398)Cardiacassist, Inc.2003-05-23
RMI INTERNAL MAMMARY ARTERY CANNULA (K960098)Research Medical, Inc.1996-03-26
MODIFIED SHILEY FEMORAL VENOUS CANNULA (K894784)Shiley, Inc.1990-03-28
RMI ARTERIAL PERFUSION CANNULA (K894243)Research Medical, Inc.1989-09-19
HARBORIN CENTRAL VENOUS CATHETER (K884628)Harbor Medical Devices, Inc.1989-05-15
DAIG COLLAPSIBLE STERILE SLEEVE (K884478)Daig Corp.1989-02-22
TRANSLUMBAR AORTOGRAPHY NEEDLE CATHETER (K884375)Argon Medical Corp.1989-01-11
ASK-300 (K882977)Medical Repackers Co.1989-01-05
HARBOR CENTRAL VENOUS CATHETER (K881884)Harbor Medical Devices, Inc.1988-07-28

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