Traxcess Pro 14 Guidewire
FDA 510(k) clearance K153053 · decided 2015-12-29
Clearance details
- K-number
- K153053
- Device name
- Traxcess Pro 14 Guidewire
- Applicant
- MicroVention, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-10-20
- Decision date
- 2015-12-29
- Days to decision
- 70 days
- Clearance type
- Special
- Product code
- MOF
- Device class
- 2
- Regulation number
- 870.1330
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Tustin, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch MicroVention
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 |
|---|---|---|
| Aristotle Mini Guidewire (K260223) | Scientia Vascular, Inc. | 2026-08-06 |
| Drivewire 35 Guidewire (K254006) | Rapid Medical Ltd. | 2026-07-17 |
| Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire (K253579) | Scientia Vascular, Inc. | 2026-04-29 |
| Zenith Micro Guidewire (K252317) | Suzhou Zenith Vascular SciTech Limited | 2026-04-16 |
| Willow 24 Guidewire (K260537) | Arbor Endovascular, LLC | 2026-03-19 |
| DCwire Micro-guidewire (K252122) | Shanghai Achieva Medical Suzhou Co., Ltd. | 2026-03-16 |
| Willow 18 Guidewire (K260130) | Arbor Endovascular, LLC | 2026-02-13 |
| CHIKAI Nexus petit (K252011) | Asahi Intecc Co., Ltd. | 2026-02-02 |
| 0.014” Willow Guidewire (K253168) | Arbor Endovascular, LLC | 2025-11-26 |
| X-Wire Guidewire (K244061) | Imperative Care, Inc. | 2025-08-26 |
| 0.014” Willow Guidewire (K243756) | Arbor Endovascular, LLC | 2025-07-17 |
| CHIKAI Nexus 014 (K243383) | Asahi Intecc Co., Ltd. | 2025-04-21 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Flow Re-Direction Endoluminal Device (FRED®) System (P180027/S013) | MicroVention, Inc. | 2025-11-02 |
| Flow Re-Direction Endoluminal Device (FRED) X System (P180027/S012) | MicroVention, Inc. | 2025-09-20 |
| FRED X System (P180027/S014) | MicroVention, Inc. | 2025-09-18 |
| Roadsaver/CASPER Carotid Stent Device (P210030/S001) | MicroVention, Inc. | 2025-06-23 |
| Roadsaver/CASPER Carotid Stent Device (P210030) | MicroVention, Inc. | 2024-11-20 |
| Woven EndoBridge Aneurysm Embolization (WEB) System (P170032/S017) | MicroVention, Inc. | 2024-09-23 |
| Low-Profile Visualized Intraluminal Support (LVIS), LVIS Jr (P170013/S012) | MicroVention, Inc. | 2024-08-21 |
| Flow Re-Direction Endoluminal Device (FRED®) System (P180027/S011) | MicroVention, Inc. | 2024-08-21 |