SUBCUPASS TUNNELING TOOL
FDA 510(k) clearance K780579 · decided 1978-05-19
Clearance details
- K-number
- K780579
- Device name
- SUBCUPASS TUNNELING TOOL
- Applicant
- Medtronic Vascular
- Decision
- Substantially Equivalent
- Date received
- 1978-04-10
- Decision date
- 1978-05-19
- Days to decision
- 39 days
- Clearance type
- Traditional
- Product code
- HAO
- Device class
- 1
- Regulation number
- 882.4535
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Medtronic Vascular
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Matreneu Percutaneous Balloon Compression Kit (K220920) | Shenzhen Shineyard Medical Device Co. , Ltd. | 2022-09-07 |
| MULLAN GANGLION MICROCOMPRESSION SET (K940973) | Cook, Inc. | 1995-09-29 |
| RIB RESECTOR (K951492) | United States Surgical, A Division of Tyco Healthc | 1995-05-18 |
| AUTO SUTURE PITUITARY SPINAL RONGEUR (K943115) | United States Surgical, A Division of Tyco Healthc | 1994-07-25 |
| AUTO SUTURE SPINAL DISSECTOR (K942971) | United States Surgical, A Division of Tyco Healthc | 1994-07-20 |
| AUTO SUTURE SPINAL CURETTE (K942967) | United States Surgical, A Division of Tyco Healthc | 1994-07-20 |
| AUTO SUTURE SPINAL ELEVATOR (K942970) | United States Surgical, A Division of Tyco Healthc | 1994-07-20 |
| AUTO SUTURE SPINAL OSTEOTOME (K942968) | United States Surgical, A Division of Tyco Healthc | 1994-07-20 |
| AUTO SUTURE SPINAL NERVE HOOK (K942969) | United States Surgical, A Division of Tyco Healthc | 1994-07-20 |
| SILICONE BRAIN SPATULA SET (K923723) | Redmond Neurosurgical, Inc. | 1992-08-12 |
| BONE PAD REMOVER (K910225) | Acra Cut, Inc. | 1991-02-12 |
| DURAL DISSECTORS (K910226) | Acra Cut, Inc. | 1991-02-12 |
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 |