Hancock * Obturators

FDA 510(k) K801885 · Hancock Laboratories, Inc.

Substantially Equivalent

510(k) numberK801885

Submission

Device name
Hancock * Obturators
Applicant
Hancock Laboratories, Inc.
Mchenry, IL, US
Received
August 7, 1980
Decision date
September 9, 1980
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DTI – Sizer, Heart-Valve, Prosthesis
Device class
Class I (low risk)
Regulation
21 CFR 870.3945
Specialty
Cardiovascular

Other 510(k)s with product code DTI

510(k)DeviceApplicantDecision
K952184Carbomedics Supra-Annular Valve SizerDTI · Traditional Carbomedics, Inc.11/29/1995SE
K934951Valve SizerDTI · Traditional Carbomedics, Inc.12/10/1993SE
K881279Edwards-Duromedics Bileaflet Valve Sizer SetDTI · Traditional Baxter Healthcare Corp05/18/1988SE
K853313Duromedics Cardiac Valve Sizer SetDTI · Traditional Hemex Scientific, Inc.11/01/1985SE
K852612Metronic Model F7700 Heart Valve SizersDTI · Traditional Medtronic Vascular09/23/1985SE
K820887Mitral Valve Orifice SizerDTI · Traditional Celtech07/08/1982SE

More from Celtech

510(k)DeviceDecision
K800703Modified Catheter PackageDQO · Traditional 04/08/1980SE
K800122Hancock Aortic PunchDWS · Traditional 02/01/1980SE
K790534Mersilene SuturesKRH · Traditional 03/26/1979SE
K780568Duran Flexible Ring · Traditional 05/26/1978SE

Questions and answers

When was Hancock * Obturators cleared by the FDA?

Hancock * Obturators (K801885) received a 510(k) decision of Substantially Equivalent on September 9, 1980, 33 days after the submission was received.

What is the product code of K801885?

The FDA product code is DTI – Sizer, Heart-Valve, Prosthesis, a Class I (low risk) device regulated under 21 CFR 870.3945.