Cardicad(Tm)

FDA 510(k) K881392 · Medical/Surgical Specialties, Ltd.

Substantially Equivalent

510(k) numberK881392

Submission

Device name
Cardicad(Tm)
Applicant
Medical/Surgical Specialties, Ltd.
Kalamazoo, MI, US
Received
April 4, 1988
Decision date
May 31, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DWS – Instruments, Surgical, Cardiovascular
Device class
Class I (low risk)
Regulation
21 CFR 870.4500
Specialty
Cardiovascular

Other 510(k)s with product code DWS

510(k)DeviceApplicantDecision
K022238Myocardial Lead Implant Tool, Model 10626DWS · Traditional Medtronic Vascular10/09/2002SE
K964445Octopus Tissue Stabilizer (28001/28002/28003/28004/28005/28006)DWS · Traditional Dlp, Inc.01/30/1997SE
K962771Burke Congenital Thoracoscopy InstrumentsDWS · Traditional Pilling Weck, Inc.11/19/1996SE
K955689RNS Sterile, Disposable Digital Angiographic TrayDWS · Traditional Contour Fabricators of Florida, Inc.05/15/1996SE
K960139G.E. Sterile Angiographic TrayDWS · Traditional GE Medical Systems04/19/1996SESK
K960144G.E. Sterile CT Biopsy TrayDWS · Traditional GE Medical Systems04/15/1996SESK
K960143G.E. Sterile Digital Angiographic TrayDWS · Traditional GE Medical Systems04/09/1996SESK
K934727Replacement Parts for Cpi 6888 Lead TunnelerDWS · Traditional Cardiac Pacemakers, Inc.01/10/1994SE
K900379Hycult Diamond Coronary Bypass KnifeDWS · Traditional St. Jude Medical, Inc.03/19/1990SE
K896307Insulation PadDWS · Traditional Bio-Vascular, Inc.01/19/1990SE

More from Bio-Vascular, Inc.

510(k)DeviceDecision
K895677The Murray Mobilift(Tm)FNG · Traditional 10/26/1990SE
K900633Disp. Electrosurgery Pencil, Hand ControlGEI · Traditional 05/07/1990SE
K881427Spirix(Tm)GEI · Traditional 04/19/1988SE

Questions and answers

When was Cardicad(Tm) cleared by the FDA?

Cardicad(Tm) (K881392) received a 510(k) decision of Substantially Equivalent on May 31, 1988, 57 days after the submission was received.

What is the product code of K881392?

The FDA product code is DWS – Instruments, Surgical, Cardiovascular, a Class I (low risk) device regulated under 21 CFR 870.4500.