Astra T2, Astra T4, Astra T6
FDA 510(k) K920601 · Cardiac Pacemakers, Inc.
510(k) numberK920601
Submission
- Device name
- Astra T2, Astra T4, Astra T6
- Applicant
- Cardiac Pacemakers, Inc.
St. Paul, MN, US - Received
- February 11, 1992
- Decision date
- October 28, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K093969 | Acuity Break-Away Guide CatheterDQY · Special | 03/05/2010SE |
| K080154 | Acuity Universal CutterDQY · Special | 03/20/2008SE |
| K934727 | Replacement Parts for Cpi 6888 Lead TunnelerDWS · Traditional | 01/10/1994SE |
| K912379 | PDT Carryall Transmitter, Various ModelsDXH · Traditional | 06/17/1991SE |
| K905674 | Lead StyletDRB · Traditional | 01/30/1991SE |
| K900498 | Modified Betatron IV Insulin Infusion SystemLZG · Traditional | 02/23/1990SE |
| K894738 | Model 6888 Lead TunnelerDWS · Traditional | 09/13/1989SE |
| K890785 | Astra T2, T3, T4, T6 Pulse Generators New PackageDXY · Traditional | 03/10/1989SE |
| K875147 | Torque Hex WrenchDTF · Traditional | 01/27/1988SE |
| K872774 | Betatron IV SystemFRN · Traditional | 01/05/1988SE |
Questions and answers
When was Astra T2, Astra T4, Astra T6 cleared by the FDA?
Astra T2, Astra T4, Astra T6 (K920601) received a 510(k) decision of Substantially Equivalent on October 28, 1992, 260 days after the submission was received.
What is the product code of K920601?
The FDA product code is DXY – Implantable Pacemaker Pulse-Generator, a Class III (high risk) device regulated under 21 CFR 870.3610.