Telectronics Pacing Systems VS-1 to 6MM Upsizing
FDA 510(k) K895971 · Telectronics Pacing Systems, Inc.
510(k) numberK895971
Submission
- Device name
- Telectronics Pacing Systems VS-1 to 6MM Upsizing
- Applicant
- Telectronics Pacing Systems, Inc.
Englewood, CO, US - Received
- October 13, 1989
- Decision date
- February 22, 1990
- 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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| K971930 | Bk-N Sealing CapDTD · Traditional | Biotronik, Inc. | 08/14/1997PT |
More from Biotronik, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K961118 | Maxim PF Models 033-581/033-590DTB · Traditional | 07/15/1996ST |
| K943657 | SterilizationDTB · Traditional | 06/24/1996ST |
| K934899 | Bifurcated Lead Adaptors, 3.2MM & 5.0 MMDTD · Traditional | 05/12/1994SE |
| K926340 | New Lead Introducer Kits, Various ModelsDYB · Traditional | 05/27/1993SE |
| K914489 | New Extrusion Vendor for Polyurethane TubingDTB · Traditional | 08/17/1992SE |
| K913919 | Universal Terminal Cap, 3.2MMKFJ · Traditional | 12/31/1991SE |
| K912773 | Unipolar Upsizing AdaptorDTD · Traditional | 10/23/1991SE |
| K911273 | 100 CM Permanent Pacing Lead ModelsDTB · Traditional | 08/28/1991SE |
| K910112 | Bifurcated VS-1 to VS-1 Lead AdaptorDTD · Traditional | 02/25/1991SE |
| K903186 | Optima Series II Model 147B Single Chamber PulseDXY · Traditional | 01/18/1991SE |
Questions and answers
When was Telectronics Pacing Systems VS-1 to 6MM Upsizing cleared by the FDA?
Telectronics Pacing Systems VS-1 to 6MM Upsizing (K895971) received a 510(k) decision of Substantially Equivalent on February 22, 1990, 132 days after the submission was received.
What is the product code of K895971?
The FDA product code is DTD – Pacemaker Lead Adaptor, a Class II (moderate risk) device regulated under 21 CFR 870.3620.