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FDA 510(k)

Viatrac 14 Plus Peripheral Dilatation Catheter

K-Number: K221057 · 2022-05-05

ApplicantAbbott Vascular
Decision Date2022-05-05
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Viatrac 14 Plus Peripheral Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Vascular. It received FDA 510(k) clearance on 2022-05-05 under 510(k) number K221057. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Viatrac 14 Plus Peripheral Dilatation Catheter?

Viatrac 14 Plus Peripheral Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2022-05-05. The listed applicant is Abbott Vascular. The 510(k) number is K221057.

When did Viatrac 14 Plus Peripheral Dilatation Catheter receive FDA 510(k) clearance?

Viatrac 14 Plus Peripheral Dilatation Catheter received FDA 510(k) clearance on 2022-05-05, under 510(k) number K221057.

Who is the listed applicant for Viatrac 14 Plus Peripheral Dilatation Catheter?

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

What is the FDA product code for Viatrac 14 Plus Peripheral Dilatation Catheter?

The FDA product code for Viatrac 14 Plus Peripheral Dilatation Catheter is LIT.

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.

NCT06675786The Effect of Catheter Protector on Catheter Dwell Time and ComplicationsCOMPLETEDNCT06832631VITUS Post-Market RegistryACTIVE_NOT_RECRUITING

Other records listing Abbott Vascular 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.

PMA P110019Coronary drug-eluting stentPMA P960043Device, hemostasis, vascularPMA P040038Stent, carotidPMA P110028STENT, ILIACPMA P110001STENT, RENALPMA P040012Stent, carotid

View all 21 devices →

Related Devices (Code: LIT)

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.

K260304WAVE PTA Balloon CatheterWAVE Medical AGK252512Armada™ 14 NC PTA CatheterABBOTT MEDICALK251915Amethyst HP PTA OTW 0.035 CatheterNatec Medical , Ltd.K250706Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) CatheterBiotronik, Inc.K243704Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd.K241040Amethyst HP PTA OTW 0.035 CatheterNatec Medical , Ltd.

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.

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