Beta-Cap

FDA 510(k) K771420 · Quinton, Inc.

Substantially Equivalent

510(k) numberK771420

Submission

Device name
Beta-Cap
Applicant
Quinton, Inc.
Mchenry, IL, US
Received
August 1, 1977
Decision date
November 28, 1977
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
FJS – Catheter, Peritoneal, Long-Term Indwelling
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5630
Specialty
Gastroenterology, Urology
Implant
Yes

Other 510(k)s with product code FJS

510(k)DeviceApplicantDecision
K213602Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter…FJS · Traditional Covidien, LLC01/14/2022SE
K180485Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialysis…FJS · Traditional Covidien, LLC07/27/2018SESK
K130441Faller StyletFJS · Traditional Medionics International, Inc.04/19/2013SE
K121383PS X Series (Basic Components and Catheter), PD X Series (Catheter with All Components)FJS · Traditional Medical Components, Inc.09/05/2012SESK
K120130Faller TrocarFJS · Traditional Medigroup, Inc.05/21/2012SE
K113354Veta Peritoneal Dialysis CatheterFJS · Traditional Pfm Medical, Inc.03/13/2012SESK
K071167Flex-Neck Exxtended Peritoneal Dialysis Catheter and Accessories, Model CF-5560FJS · Traditional Medigroup, Inc.08/31/2007SESK
K070730Flex-Neck Arc CatheterFJS · Traditional Medigroup, Inc.07/03/2007SESK
K060897Embedding Tool, Model TE-1000FJS · Traditional Medigroup, Inc.07/18/2006SE
K053123PD CathFJS · Traditional Med-Conduit, Inc.03/29/2006SE

More from Med-Conduit, Inc.

510(k)DeviceDecision
K032038Pyramis ECG Management System Model Numbers, 92600 and 92601DQK · Abbreviated 09/05/2003SE
K021906Quinton Q-Cath, Model 000460DQK · Abbreviated 09/04/2002SE
K003576Q-Tel RMS (Rehabilitation Management System), Model 000503DSI · Abbreviated 01/25/2001SE
K001492Quinton Q-Stress, Model 000483DPS · Abbreviated 08/09/2000SE
K992908Q-Tel Telemetry System V. 6.0 (ST)DSI · Traditional 03/06/2000SE
K990866Quinton Medtrack CR Plus TreadmillISD · Traditional 04/29/1999SE
K971397Viewcath 3-D Catheter PullbackITX · Traditional 08/25/1997SE
K964784Synergy Cardiology Information System (00431)DPS · Traditional 08/13/1997SE
K964978Vital Statistics System (O-Cath Accessory)DQA · Traditional 05/21/1997SE
K955002Mahurkar 8 FR Dual Lemen CatheterMPB · Traditional 09/13/1996SE

Questions and answers

When was Beta-Cap cleared by the FDA?

Beta-Cap (K771420) received a 510(k) decision of Substantially Equivalent on November 28, 1977, 119 days after the submission was received.

What is the product code of K771420?

The FDA product code is FJS – Catheter, Peritoneal, Long-Term Indwelling, a Class II (moderate risk) device regulated under 21 CFR 876.5630.