TEMPORARY SCREENING LEAD/ CATHETER KIT
FDA 510(k) clearance K934939 · decided 1995-05-24
Clearance details
- K-number
- K934939
- Device name
- TEMPORARY SCREENING LEAD/ CATHETER KIT
- Applicant
- Medtronic Vascular
- Decision
- Substantially Equivalent
- Date received
- 1993-10-18
- Decision date
- 1995-05-24
- Days to decision
- 583 days
- Clearance type
- Traditional
- Product code
- MAJ
- Device class
- 2
- Regulation number
- 868.5120
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- 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 |
|---|---|---|
| MEDTRONIC ALGOLINE INTRASPINAL CATHETER SYSTEM (K965251) | Medtronic Vascular | 1997-03-18 |
| MEDTRONIC MODEL 3864C & 3865C TEMPORARY SCREENING LEAD/CATHETER KIT (K945413) | Medtronic Vascular | 1995-05-24 |
| SUBCUTANEOUS TUNNELING NEEDLE AND HANDLES (K930218) | Concord/Portex | 1993-07-27 |
| IPI ALGO-LINE CATHETER (K911382) | Pudenz-Schulte Medical Research Corp. | 1991-07-18 |
| LIFECARE CONT. EPIDURAL CATH. FOR MORPHINE SULFATE (K893766) | Abbott Laboratories | 1989-11-01 |
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 |