Model 4810 Analyzer Output Adapter
FDA 510(k) K002497 · Pace Medical
510(k) numberK002497
Submission
- Device name
- Model 4810 Analyzer Output Adapter
- Applicant
- Pace Medical
Waltham, MA, US - Received
- August 14, 2000
- Decision date
- October 10, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DTC – Analyzer, Pacemaker Generator Function
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3630
- Specialty
- Cardiovascular
Other 510(k)s with product code DTC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K170815 | PSA CableDTC · Traditional | Boston Scientific Corporation | 07/06/2017SE |
| K083674 | PK-141 Patient CableDTC · Traditional | Biotronik, Inc. | 04/01/2009SE |
| K011729 | Sigma Pace External Pacemaker Analyzer Model #1000DTC · Traditional | Dni Nevada, Inc. | 08/30/2001SE |
| K961582 | External Pacemaker Analyzer, Model PMT 100DTC · Traditional | North American Technical Services Corp. | 11/08/1996SE |
| K903966 | External Pacemaker Analyzer Model PMA-1DTC · Traditional | Bio-Tek Instruments, Inc. | 06/19/1991SE |
| K910595 | Model 5311B A-V Pacing System AnalyzerDTC · Traditional | Medtronic Vascular | 05/07/1991SE |
| K910223 | Cpi Model 2215/SEAMED Model 3400DTC · Traditional | Seamed Corp. | 03/19/1991SE |
| K901332 | PK-55 Andover Medical Part #5455 Label ChangeDTC · Traditional | Biotronik, GmbH & Co. | 05/09/1990SE |
| K896632 | Medtronic Model 5401B Test CableDTC · Traditional | Medtronic Vascular | 12/13/1989SE |
| K884331 | Medtronic Model 5311B A-V Pacing System AnalyzerDTC · Traditional | Medtronic Vascular | 01/10/1989SE |
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 |
| 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 |
| K913134 | Model 4220DXY · Traditional | 08/22/1991SE |
Questions and answers
When was Model 4810 Analyzer Output Adapter cleared by the FDA?
Model 4810 Analyzer Output Adapter (K002497) received a 510(k) decision of Substantially Equivalent on October 10, 2000, 57 days after the submission was received.
What is the product code of K002497?
The FDA product code is DTC – Analyzer, Pacemaker Generator Function, a Class II (moderate risk) device regulated under 21 CFR 870.3630.