MODEL 2331T PATIENT PROGRAMMER
FDA 510(k) clearance K880738 · decided 1988-11-17
Clearance details
- K-number
- K880738
- Device name
- MODEL 2331T PATIENT PROGRAMMER
- Applicant
- Medtronic Vascular
- Decision
- Substantially Equivalent
- Date received
- 1988-02-24
- Decision date
- 1988-11-17
- Days to decision
- 267 days
- Clearance type
- Traditional
- Product code
- KRG
- Device class
- 3
- Regulation number
- 870.3700
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Minneapolis, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| INTERMEDICS TRIANGLE CHEST PROBE MODEL 526-04 (K933278) | Intermedics, Inc. | 1995-03-15 |
| MODEL 5650 OPTIMATE PERSONAL PROGRAMMER (K884522) | Teletronics, Inc. | 1989-08-25 |
| MODEL 255A PROGRAMMER III, W/SOFTWARE REVI. 4004 (K882429) | Tpl-Cordis, Inc. | 1988-07-22 |
| MODEL 1740 PERSONAL POCKET PROGRAMMER (K864712) | Telectronics, Inc. | 1987-12-17 |
| MODEL 5600B PROGRAMMER, PACEMAKER (K871986) | Telectronics, Inc. | 1987-06-24 |
| ULTRA SOFTWARE MODULE: MODEL 2016 (K863046) | Cardiac Pacemakers, Inc. | 1986-12-05 |
| PROGRAMMER MODEL 2035/ELECTROGRAM CABLE MODEL 6580 (K863045) | Cardiac Pacemakers, Inc. | 1986-09-29 |
| SOFTWARE MODULE/2035 PROG AND ASTRA/T PULSE GEN (K860584) | Cardiac Pacemakers, Inc. | 1986-06-06 |
| DIALOG PROGRAMMER 700 - PROGRAM VERSION 6.37 (K860546) | Pacesetter Systems | 1986-04-23 |
| HEWLETT PACKARDT HP 85 W/ VITATRON PH1 PROGRAM HEA (K844484) | Vitatron Medical BV | 1985-07-24 |
| CERYX6, 611, CERYX 3 311 & CERYX 1 111 (K844485) | Vitatron Medical BV | 1985-04-19 |
| TP 1 (K844483) | Vitatron Medical BV | 1985-04-19 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System - RX and OTW; Onyx Frontier Zotarolimus-Eluting Coronary Stent S (P160043/S089) | Medtronic Vascular | 2025-12-19 |
| Endurant II/IIs Stent Graft System (P100021/S131) | Medtronic Vascular | 2025-10-23 |
| Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System (P100021/S129) | Medtronic Vascular | 2025-09-15 |
| Resolute Onyx (P160043/S088) | Medtronic Vascular | 2025-06-26 |
| Endurant Stent Graft System (P100021/S130) | Medtronic Vascular | 2025-06-12 |
| Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S073) | Medtronic Vascular | 2025-06-12 |
| Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S072) | Medtronic Vascular | 2025-05-20 |
| Valiant Thoracic Stent Graft with the Captiva Delivery System (P100040/S069) | Medtronic Vascular | 2025-05-08 |