VS-1 Model Number 251K Pulse Generator
FDA 510(k) K885267 · Pacesetter Systems
510(k) numberK885267
Submission
- Device name
- VS-1 Model Number 251K Pulse Generator
- Applicant
- Pacesetter Systems
Sylmar, CA, US - Received
- December 22, 1988
- Decision date
- March 28, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K910924 | Endocardial Leads-Mod. to the PolyvinylpyrrolidoneDTB · Traditional | 08/28/1991SE |
| K902147 | Endocardial Screw-In Lead Model 1028TDTB · Traditional | 07/17/1990SE |
| K900512 | Siemens Elema Models 4020T and 4021T AdaptersDTD · Traditional | 06/25/1990SE |
| K900550 | Fast-Pass Ace Models 1212T/1222T/1216T/1226TDTB · Traditional | 04/20/1990SE |
| K895447 | Endocardial Screw-In Lead Model 1020TDTB · Traditional | 12/20/1989SE |
| K891905 | Cardiovascular Permanent Pacemaker ElectrodeDTB · Traditional | 06/05/1989SE |
| K890547 | Siemens Elema Models 4025 and 4026 AdaptersDTB · Traditional | 03/22/1989SE |
| K884733 | Afp Model 262T Pulse GeneratorDXY · Traditional | 02/10/1989SE |
| K883087 | Prolog MP 658M Pulse GeneratorDXY · Traditional | 09/14/1988SE |
| K874205 | Endocardial Screw-In Lead, Model 1018TDTB · Traditional | 02/02/1988SE |
Questions and answers
When was VS-1 Model Number 251K Pulse Generator cleared by the FDA?
VS-1 Model Number 251K Pulse Generator (K885267) received a 510(k) decision of Substantially Equivalent on March 28, 1989, 96 days after the submission was received.
What is the product code of K885267?
The FDA product code is DXY – Implantable Pacemaker Pulse-Generator, a Class III (high risk) device regulated under 21 CFR 870.3610.