Model 4220
FDA 510(k) K913134 · Pace Medical
510(k) numberK913134
Submission
- Device name
- Model 4220
- Applicant
- Pace Medical
Waltham, MA, US - Received
- July 16, 1991
- Decision date
- August 22, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DXY – Implantable Pacemaker Pulse-Generator
- Device class
- Class III (high risk)
- Regulation
- 21 CFR 870.3610
- Specialty
- Cardiovascular
- Implant
- Yes
Other 510(k)s with product code DXY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K993434 | Pikos 01, Pikos E01, Pikos 01-B, Pikos E01-B, Pikos 01-A, Pikos E01-ADXY · Special | Biotronik, Inc. | 11/10/1999SE |
| K970072 | Opus S Model 4121 and 4124 PacemakersDXY · Traditional | Ela Medical, Inc. | 08/29/1997ST |
| K945627 | Pikos LP 01, Pikos LP E01DXY · Traditional | Biotronik, Inc. | 03/04/1996SESP |
| K954092 | Alternate Sterlization Process & Modified DF-1 Lead Connector (Modification)DXY · Traditional | Medtronic Vascular | 12/15/1995ST |
| K953866 | Minix 834M & Minix ST 8331M Pulse Generators (Modification)DXY · Traditional | Medtronic Vascular | 12/15/1995ST |
| K953417 | Miniflex Model 340, 341, and 342 Pulse GeneratorsDXY · Traditional | Cook Pacemaker Corp. | 09/29/1995ST |
| K952328 | Nanos, Pikos 01/E01, 01-A, E01-B, LP 01/LP E01DXY · Traditional | Biotronik, Inc. | 09/29/1995ST |
| K952364 | Opus Pacemakers (Models 4001, 4003, 4004, 4023, 4024)DXY · Traditional | Ela Medical, Inc. | 09/01/1995ST |
| K940039 | Pellethane 75DDXY · Traditional | Medtronic Vascular | 07/12/1995ST |
| K950751 | Tecothane 75D Polyurethane Resin for Pulse Generator Connector ModulesDXY · Traditional | Medtronic Vascular | 05/15/1995ST |
More from Medtronic Vascular
| 510(k) | Device | Decision |
|---|---|---|
| K011980 | Adapter, Pacing Analyzer/Universal Pacing Adapter, Models 4820 and 4825DTE · Traditional | 09/12/2001SE |
| K012392 | Disposable Surgical Extension Cable, Model 4255 and Model 4260DSA · Traditional | 09/04/2001SE |
| K002204 | Pacemaker Extension Cable Models 4265,4265A, 4265V, 5265, 5265A, 5265VDTE · Traditional | 10/18/2000SE |
| K002497 | Model 4810 Analyzer Output AdapterDTC · Traditional | 10/10/2000SE |
| K002496 | Model 4815 AdapterDTN · Traditional | 10/10/2000SE |
| K001180 | Temporary Pacemaker Extension Cable, Models 5235, 5235A, 5235V, Temporary Pacemaker…DTE · Traditional | 06/27/2000SE |
| K925143 | Model 4800 Accupace Pacing System AnalyerDTE · Traditional | 09/27/1994SE |
| K931662 | Lead Introducer Set, Various Models and SizesDYB · Traditional | 08/31/1993SE |
| K922899 | Model 4280 Surgical Extension CableDSA · Traditional | 12/23/1992SE |
| K913805 | Miniature Models 4562/4563/4572/4573 PacemakerDTE · Traditional | 11/19/1991SE |
Questions and answers
When was Model 4220 cleared by the FDA?
Model 4220 (K913134) received a 510(k) decision of Substantially Equivalent on August 22, 1991, 37 days after the submission was received.
What is the product code of K913134?
The FDA product code is DXY – Implantable Pacemaker Pulse-Generator, a Class III (high risk) device regulated under 21 CFR 870.3610.