Model 5311B A-V Pacing System Analyzer
FDA 510(k) K910595 · Medtronic Vascular
510(k) numberK910595
Submission
- Device name
- Model 5311B A-V Pacing System Analyzer
- Applicant
- Medtronic Vascular
Minneapolis, MN, US - Received
- February 12, 1991
- Decision date
- May 7, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K002497 | Model 4810 Analyzer Output AdapterDTC · Traditional | Pace Medical | 10/10/2000SE |
| 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 |
| 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 |
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Questions and answers
When was Model 5311B A-V Pacing System Analyzer cleared by the FDA?
Model 5311B A-V Pacing System Analyzer (K910595) received a 510(k) decision of Substantially Equivalent on May 7, 1991, 84 days after the submission was received.
What is the product code of K910595?
The FDA product code is DTC – Analyzer, Pacemaker Generator Function, a Class II (moderate risk) device regulated under 21 CFR 870.3630.