Atlas FDA

HARBORIN CENTRAL VENOUS CATHETER

FDA 510(k) clearance K884628 · decided 1989-05-15

Clearance details

K-number
K884628
Device name
HARBORIN CENTRAL VENOUS CATHETER
Applicant
Harbor Medical Devices, Inc.
Decision
Substantially Equivalent
Date received
1988-11-07
Decision date
1989-05-15
Days to decision
189 days
Clearance type
Traditional
Product code
DQR
Device class
2
Regulation number
870.1300
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Boston, MA, 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
DATASCOPE ARTERIAL CANNULA W/ACCESS PORT (K902674)Datascope Corp.1991-01-16
MODIFIED SHILEY FEMORAL VENOUS CANNULA (K894784)Shiley, Inc.1990-03-28
RMI ARTERIAL PERFUSION CANNULA (K894243)Research Medical, Inc.1989-09-19
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.