Biosurge Model ILVC-1

FDA 510(k) K875016 · Biosurge, Inc.

Substantially Equivalent

510(k) numberK875016

Submission

Device name
Biosurge Model ILVC-1
Applicant
Biosurge, Inc.
Rochester, NY, US
Received
December 4, 1987
Decision date
February 29, 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
K884620Asd Single Lumen NeedleFMI · Traditional 11/21/1988SE
K874602Asd-Bio Anti-Stick DeviceFMI · Traditional 02/19/1988SE
K875023Biosurge Model Oasys-IiCAC · Traditional 02/12/1988SE
K871258Biosurge Model OasysCAC · Traditional 05/21/1987SE

Questions and answers

When was Biosurge Model ILVC-1 cleared by the FDA?

Biosurge Model ILVC-1 (K875016) received a 510(k) decision of Substantially Equivalent on February 29, 1988, 87 days after the submission was received.

What is the product code of K875016?

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