Stiff Stylets

FDA 510(k) K802076 · Cardiac Pacemakers, Inc.

Substantially Equivalent

510(k) numberK802076

Submission

Device name
Stiff Stylets
Applicant
Cardiac Pacemakers, Inc.
Walker, MI, US
Received
August 28, 1980
Decision date
September 26, 1980
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DRB – Stylet, Catheter
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1380
Specialty
Cardiovascular

Other 510(k)s with product code DRB

510(k)DeviceApplicantDecision
K220280Arrow Stiffening StyletDRB · Traditional Arrow International, LLC (A subsidiary of…08/30/2022SE
K191469Biotronik StyletsDRB · Traditional Biotronik, Inc.08/01/2019SE
K182660GaltTWSDRB · Traditional Galt Medical Corp.05/30/2019SE
K170298Liberator Beacon Tip Locking StyletDRB · Traditional Cook Incorporated10/18/2017SE
K142116LLD EzDRB · Special Spectranetics, Inc.08/12/2014SE
K090163Stylet, Models 4060, 4062, 4064, 4090, 4091 and 4078DRB · Traditional St Jude Medical04/01/2009SE
K080924Mond Rvot Stylet Models 4140, 4141, 4150, 4151DRB · Traditional St. Jude Medical, Cardiac Rhythm Management Divisi04/30/2008SE
K072864St. Jude Medical, CPS Duo Left Heart Lead Delivery SystemDRB · Traditional St. Jude Medical, Cardiac Rhythm Management Divisi03/13/2008SE
K053019Acuity Steerable Stylet AccessoryDRB · Traditional Guidant Corporation03/03/2006SE
K052965Easytrak 2 Stylet, Models 4826, 4829, 4832.DRB · Traditional Guidant Corporation02/13/2006SE

More from Guidant Corporation

510(k)DeviceDecision
K093969Acuity Break-Away Guide CatheterDQY · Special 03/05/2010SE
K080154Acuity Universal CutterDQY · Special 03/20/2008SE
K934727Replacement Parts for Cpi 6888 Lead TunnelerDWS · Traditional 01/10/1994SE
K920601Astra T2, Astra T4, Astra T6DXY · Traditional 10/28/1992SE
K912379PDT Carryall Transmitter, Various ModelsDXH · Traditional 06/17/1991SE
K905674Lead StyletDRB · Traditional 01/30/1991SE
K900498Modified Betatron IV Insulin Infusion SystemLZG · Traditional 02/23/1990SE
K894738Model 6888 Lead TunnelerDWS · Traditional 09/13/1989SE
K890785Astra T2, T3, T4, T6 Pulse Generators New PackageDXY · Traditional 03/10/1989SE
K875147Torque Hex WrenchDTF · Traditional 01/27/1988SE

Questions and answers

When was Stiff Stylets cleared by the FDA?

Stiff Stylets (K802076) received a 510(k) decision of Substantially Equivalent on September 26, 1980, 29 days after the submission was received.

What is the product code of K802076?

The FDA product code is DRB – Stylet, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1380.