Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and 3-way Stopcock (AC3200);Everest 20 Survival Kit containing:1. Everest 20 Device with 3-way Stopcock, 2. Piton Y-Adaptor ,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC2205P); Everest 30 Survival Kit containing:1. Everest 30 Device with 3-way Stopcock, 2. Piton Y-Adaptor,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC3205P)
FDA 510(k) clearance K220773 · decided 2022-04-13
Clearance details
- K-number
- K220773
- Device name
- Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and 3-way Stopcock (AC3200);Everest 20 Survival Kit containing:1. Everest 20 Device with 3-way Stopcock, 2. Piton Y-Adaptor ,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC2205P); Everest 30 Survival Kit containing:1. Everest 30 Device with 3-way Stopcock, 2. Piton Y-Adaptor,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC3205P)
- Applicant
- Medtronic Vascular
- Decision
- Substantially Equivalent
- Date received
- 2022-03-16
- Decision date
- 2022-04-13
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- MAV
- Device class
- 2
- Regulation number
- 870.1650
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Danvers, MA, 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 |
|---|---|---|
| Fluent inflation device (K162272) | Vascular Solutions, Inc. | 2016-10-20 |
| Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit (K153038) | Medtronic, Inc. | 2016-04-13 |
| basixTOUCH40 Inflation Syringe (K153672) | Merit Medical Systems, Inc. | 2016-01-20 |
| Fluent Inflation Device (K152387) | Vascular Solutions, Inc. | 2015-12-18 |
| MASTRO PLUS BALLOON IN-DEFLATION DEVICE (K140943) | Beijing Demax Medical Technology Co.,Ltd | 2015-03-05 |
| Presto Inflation Device (K143522) | C.R. Bard, Inc. | 2015-01-12 |
| SUMMED INFLATION DEVICE KIT (K133795) | Sunny Medical Device (Shenzhen) Co., Ltd. | 2014-12-12 |
| ENCORE 26 ADVANTAGE KIT (K140745) | Boston Scientific Corp | 2014-04-17 |
| BASIXTOUCH (K130566) | Merit Medical Systems, Inc. | 2013-06-19 |
| BASIXCONPAK ANALOG INFLATION SYRINGE (K122321) | Merit Medical Ireland, Ltd. | 2012-12-19 |
| OXTI INFLATION DEVICE (K122152) | Oxti Corporation | 2012-12-14 |
| ENCORE 26 ADVANTAGE KIT (K123214) | Boston Scientific Corp | 2012-11-13 |
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 |