Ultraverse 014 and 018 PTA Balloon Dilatation Catheters
FDA 510(k) clearance K192318 · decided 2019-10-03
Clearance details
- K-number
- K192318
- Device name
- Ultraverse 014 and 018 PTA Balloon Dilatation Catheters
- Applicant
- Bard Peripheral Vascular, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-08-26
- Decision date
- 2019-10-03
- Days to decision
- 38 days
- Clearance type
- Traditional
- Product code
- LIT
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Tempe, AZ, US
- Third-party review
- Yes
- 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.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Fluency Plus Endovascular Stent Graft (P130029/S015) | Bard Peripheral Vascular, Inc. | 2026-06-22 |
| Venovo Venous Stent System (P180037/S015) | Bard Peripheral Vascular, Inc. | 2026-06-10 |
| LifeStent 5F Vascular Stent Systems (P070014/S069) | Bard Peripheral Vascular, Inc. | 2026-06-10 |
| Bard Fluency Plus Endovascular Stent Graft (P130029/S014) | Bard Peripheral Vascular, Inc. | 2026-06-10 |
| LifeStent 5F Vascular Stent System (P070014/S068) | Bard Peripheral Vascular, Inc. | 2026-05-15 |
| LIFESTENT FLEXSTAR & FLEXSTAR XL VASCULAR STENT SYSTEM (P070014/S067) | Bard Peripheral Vascular, Inc. | 2026-03-10 |
| LifeStent® Vascular Stent Systems (P070014/S066) | Bard Peripheral Vascular, Inc. | 2025-12-16 |
| LifeStream Balloon Expandable Vascular Covered Stent (P160024/S014) | Bard Peripheral Vascular, Inc. | 2025-09-29 |