Lead Adapters #'S 6016,6022,6017 Etc
FDA 510(k) K831160 · Cardiac Pacemakers, Inc.
510(k) numberK831160
Submission
- Device name
- Lead Adapters #'S 6016,6022,6017 Etc
- Applicant
- Cardiac Pacemakers, Inc.
Mchenry, IL, US - Received
- April 11, 1983
- Decision date
- May 9, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DTD – Pacemaker Lead Adaptor
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3620
- Specialty
- Cardiovascular
- Implant
- Yes
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| K003454 | A1-CS-SB Y-Adapter, Model 124 871DTD · Special | Biotronik, Inc. | 01/18/2001ST |
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| K982220 | Model 2872 Bipolar Lead Adaptor KitDTD · Traditional | Medtronic Vascular | 10/15/1998ST |
| K971930 | Bk-N Sealing CapDTD · Traditional | Biotronik, Inc. | 08/14/1997PT |
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| K934727 | Replacement Parts for Cpi 6888 Lead TunnelerDWS · Traditional | 01/10/1994SE |
| K920601 | Astra T2, Astra T4, Astra T6DXY · Traditional | 10/28/1992SE |
| K912379 | PDT Carryall Transmitter, Various ModelsDXH · Traditional | 06/17/1991SE |
| K905674 | Lead StyletDRB · Traditional | 01/30/1991SE |
| K900498 | Modified Betatron IV Insulin Infusion SystemLZG · Traditional | 02/23/1990SE |
| K894738 | Model 6888 Lead TunnelerDWS · Traditional | 09/13/1989SE |
| K890785 | Astra T2, T3, T4, T6 Pulse Generators New PackageDXY · Traditional | 03/10/1989SE |
| K875147 | Torque Hex WrenchDTF · Traditional | 01/27/1988SE |
Questions and answers
When was Lead Adapters #'S 6016,6022,6017 Etc cleared by the FDA?
Lead Adapters #'S 6016,6022,6017 Etc (K831160) received a 510(k) decision of Substantially Equivalent on May 9, 1983, 28 days after the submission was received.
What is the product code of K831160?
The FDA product code is DTD – Pacemaker Lead Adaptor, a Class II (moderate risk) device regulated under 21 CFR 870.3620.