SOFIA Plus Aspiration Catheter
FDA 510(k) clearance K173200 · decided 2018-06-11
Clearance details
- K-number
- K173200
- Device name
- SOFIA Plus Aspiration Catheter
- Applicant
- MicroVention, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-10-02
- Decision date
- 2018-06-11
- Days to decision
- 252 days
- Clearance type
- Traditional
- Product code
- NRY
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Tistin, CA, 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 |
|---|---|---|
| Socrates Aspiration System (Socrates 70 Aspiration Catheter) (K260002) | Scientia Vascular, Inc. | 2026-07-16 |
| Penumbra System (Thunderbolt Aspiration Tubing) (K250690) | Penumbra, Inc. | 2026-06-10 |
| Zenith Aspiration Catheter; Disposable Aspiration Tubing Set (K252707) | Suzhou Zenith Vascular SciTech Limited | 2026-05-20 |
| Lynx Aspiration Catheter System (K254276) | Q’Apel Medical, Inc. | 2026-05-07 |
| Millipede System (K253590) | Perfuze, Ltd. | 2026-03-16 |
| Tigertriever 25 Revascularization Device (K253062) | Rapid Medical Ltd. | 2026-03-12 |
| Esperance pHLO Aspiration System (K251357) | Phenox, Ltd. | 2026-01-15 |
| NeVasc Aspiration System (K251006) | Vesalio, Inc. | 2025-11-10 |
| Zoom System (Zoom 4S Catheter) (K252046) | Imperative Care, Inc. | 2025-10-30 |
| Tigertriever 17 Ultra Revascularization Device (K251603) | Rapid Medical Ltd. | 2025-10-06 |
| EMBOTRAP III Revascularization Device (K251789) | Neuravi Limited | 2025-09-25 |
| Millipede70 Aspiration Catheter; Perfuze Aspiration Tube Set (K252392) | Perfuze, Ltd. | 2025-08-29 |
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 |