MODEL 4242 TELE SYST ARRHYTHMIA MONITOR
FDA 510(k) clearance K822955 · decided 1982-11-01
Clearance details
- K-number
- K822955
- Device name
- MODEL 4242 TELE SYST ARRHYTHMIA MONITOR
- Applicant
- Medtronic Vascular
- Decision
- Substantially Equivalent
- Date received
- 1982-10-05
- Decision date
- 1982-11-01
- Days to decision
- 27 days
- Clearance type
- Traditional
- Product code
- DXH
- Device class
- 2
- Regulation number
- 870.2920
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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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; Onyx Frontier Zotarolimus-Eluting Coronary Stent System Stent S (P160043/S094) | Medtronic Vascular | 2026-06-05 |
| RESOLUTE ONYX ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P160043/S093) | Medtronic Vascular | 2026-05-29 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System; Onyx Frontier Zotarolimus-Eluting Coronary Stent System Stent S (P160043/S092) | Medtronic Vascular | 2026-05-13 |
| Endurant II/IIs Stent Graft System (P100021/S132) | Medtronic Vascular | 2026-05-12 |
| Onyx Frontier Zotarolimus Eluting Coronary Stent System (P160043/S090) | Medtronic Vascular | 2026-03-25 |
| Endurant, Endurant II/lls Stent Graft System (P100021/S134) | Medtronic Vascular | 2026-02-27 |
| Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S074) | Medtronic Vascular | 2026-02-27 |
| Endurant Stent Graft System; Endurant II/IIs Stent Graft System; Endurant II AUI Stent Graft System (P100021/S133) | Medtronic Vascular | 2026-01-27 |