Insulation Pad

FDA 510(k) K896307 · Bio-Vascular, Inc.

Substantially Equivalent

510(k) numberK896307

Submission

Device name
Insulation Pad
Applicant
Bio-Vascular, Inc.
St. Paul, MN, US
Received
October 31, 1989
Decision date
January 19, 1990
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
K894738Model 6888 Lead TunnelerDWS · Traditional Cardiac Pacemakers, Inc.09/13/1989SE

More from Cardiac Pacemakers, Inc.

510(k)DeviceDecision
K002233Bvi SlingPAJ · Traditional 10/13/2000SE
K992537Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry (Non-Naoh-Treated and…FTM · Traditional 02/22/2000SE
K983602CV Peri-Guard and Vascu-GuardDXZ · Special 11/12/1998SE
K983581Ocu-Guard and Ocu-Guard SuppleHQX · Special 11/06/1998SE
K983162Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve…FTM · Special 10/09/1998SE
K981624Flo-ThruDXC · Traditional 08/04/1998SE
K982282Dura-Guard - Dural Repair PatchGXQ · Special 07/30/1998SE
K971726CV Peri-Guard - Cardiovascular PatchDXZ · Traditional 04/10/1998SE
K973706Dura-Guard-Dural Repair PatchGXQ · Traditional 12/24/1997SE
K973552Ocu-Guard Orbital Implant Wrap, Supple Ocu-Guard Orbital Implant WrapMTZ · Traditional 12/16/1997SE

Questions and answers

When was Insulation Pad cleared by the FDA?

Insulation Pad (K896307) received a 510(k) decision of Substantially Equivalent on January 19, 1990, 80 days after the submission was received.

What is the product code of K896307?

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