Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

UltraCor Twirl Breast Tissue Marker

K-Number: K152510 · 2016-05-13

ApplicantBard Peripheral Vascular, Inc.
Decision Date2016-05-13
Product CodeNEU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

UltraCor Twirl Breast Tissue Marker is the device name listed in this FDA 510(k) record. The listed applicant is Bard Peripheral Vascular, Inc.. It received FDA 510(k) clearance on 2016-05-13 under 510(k) number K152510. The device is classified under product code NEU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UltraCor Twirl Breast Tissue Marker?

UltraCor Twirl Breast Tissue Marker is a medical device that received FDA 510(k) clearance on 2016-05-13. The listed applicant is Bard Peripheral Vascular, Inc.. The 510(k) number is K152510.

When did UltraCor Twirl Breast Tissue Marker receive FDA 510(k) clearance?

UltraCor Twirl Breast Tissue Marker received FDA 510(k) clearance on 2016-05-13, under 510(k) number K152510.

Who is the listed applicant for UltraCor Twirl Breast Tissue Marker?

The FDA 510(k) record lists Bard Peripheral Vascular, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UltraCor Twirl Breast Tissue Marker?

The FDA product code for UltraCor Twirl Breast Tissue Marker is NEU.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT04968990Treatment of Newly Diagnosed Patient's With Wilm's Tumor Requiring Abdominal Radiation Delivered With Proton Beam IrradiationRECRUITINGNCT07562789Role of PCGEM1 in Breast CancerNOT_YET_RECRUITING

Other records listing Bard Peripheral Vascular, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262571EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemPMA P130029System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatmentPMA P180037Stent, iliac veinPMA P070014STENT, SUPERFICIAL FEMORAL ARTERYK260012UltraScore™ Focused Force PTA BalloonK252681EnCor EnCompass™ Breast Biopsy and Tissue Removal System

View all 26 devices →

Related Devices (Code: NEU)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253761HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape)Devicor Medical Products, Inc.K253888MOLLI 2 SystemStryker EndoscopyK252892SCOUT MD Surgical Guidance SystemMerit Medical Systems, Inc.K251989VizMark Preloaded Tissue Marker Device (VM-0001)Breast-Med, Inc.K251748MammoSTAR Biopsy Site IdentifierCarbon Medical Technologies, Inc.K243642UltraCor™ Twirl™ Breast Tissue MarkerBard Peripheral Vascular, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑