BARD(R) MONOPTY(R) DISPOSABLE CORE BIOPSY INSTRUMENT, BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENT
FDA 510(k) clearance K133948 · decided 2014-02-21
Clearance details
- K-number
- K133948
- Device name
- BARD(R) MONOPTY(R) DISPOSABLE CORE BIOPSY INSTRUMENT, BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENT
- Applicant
- Bard Peripheral Vascular, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-12-23
- Decision date
- 2014-02-21
- Days to decision
- 60 days
- Clearance type
- Special
- Product code
- KNW
- Device class
- 2
- Regulation number
- 876.1075
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Tempe, AZ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Bard Marquee Disposable Core Biopsy Instrument Kit: BARD MARQUEE KIT 12G X 10 CM, REF: MQK recall (Z-0467-2025) | Bard Peripheral Vascular Inc | 2024-11-15 |
| Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016 recall (Z-0027-2024) | Bard Peripheral Vascular Inc | 2023-10-04 |
| BARD MAX-CORE Disposable Core Biopsy Instrument Gauge x Length 18g x 20cm The BARD MAX-COR recall (Z-1586-2015) | Bard Peripheral Vascular Inc | 2015-05-06 |
| Bard Monopty Disposable Core Biopsy Instruments and Kits, Monopty 14g x 16cm (22mm), Produ recall (Z-1447-2015) | Bard Peripheral Vascular Inc | 2015-04-14 |
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 |