510(k) K133948 ยท KNW Instrument, Biopsy
BARD(R) MONOPTY(R) DISPOSABLE CORE BIOPSY INSTRUMENT, BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENT
| Applicant | Bard Peripheral Vascular, Inc., Tempe AZ, US |
| Decision | Substantially Equivalent, Feb 21, 2014 |
| Received | Dec 23, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K133948
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 15, 2024 | Bard Peripheral Vascular Inc Bard Marquee Disposable Core Biopsy Instrument Kit:
BARD MARQUEE KIT 12G X 10 CM, REF: MQK1210;
BARD MARQUEE 12G X 10 CM, REF: MQ1210;
BARD MARQUEE Kit 12G X 13 CM, REF: MQK1213;
BARD MARQUEE 12G X 13 Open, Classified |
KNW | None listed |
| Oct 4, 2023 | Bard Peripheral Vascular Inc Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016 Open, Classified |
KNW | None listed |
| Jan 14, 2021 | Bard Peripheral Vascular Inc BARD MARQUEE Disposable Core Biopsy Instruments XX.Xcm, XX.Xcm, XXg x XXcm REF XXXXXXX
Note - for definition of the "X's refer to Tyvek Lid Label.pdf" uploaded in Associated Documents Terminated |
KNW | None listed |
| Oct 25, 2019 | Bard Peripheral Vascular Inc BARD MAX-CORE Disposable Core Biopsy Instrument - Product Usage: The core needle biopsy device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymp Terminated |
KNW | None listed |
| Sep 22, 2017 | Bard Peripheral Vascular Inc BARD MAX-CORE Disposable Core Biopsy Instrument, Product Codes - MC1410, 14 g x 10 cm; MC1616, 16 g x 16 cm; MC1816, 18 g x 16 cm; MC1820, 18 g x 20 cm; MC1825, 18 g x 25 cm.
The core needle biopsy Terminated |
KNW | None listed |
| May 6, 2015 | Bard Peripheral Vascular Inc BARD MAX-CORE Disposable Core Biopsy Instrument
Gauge x Length
18g x 20cm
The BARD MAX-CORE Disposable Core Biopsy Instrument is a single patient use core biopsy device. It is available in several Terminated |
KNW | None listed |
| Apr 14, 2015 | Bard Peripheral Vascular Inc Bard Monopty Disposable Core Biopsy Instruments and Kits, Monopty 14g x 16cm (22mm), Product Code: 121416; Monopty Biopsy, Product Code: 000441; Monopty 14g x 10cm (22mm), Product Code: 121410; Monopt Terminated |
KNW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.