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)

RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER

K-Number: K130911 · 2013-05-24

ApplicantEv3, Inc.
Decision Date2013-05-24
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Ev3, Inc.. It received FDA 510(k) clearance on 2013-05-24 under 510(k) number K130911. 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 RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER?

RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER is a medical device that received FDA 510(k) clearance on 2013-05-24. The listed applicant is Ev3, Inc.. The 510(k) number is K130911.

When did RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER receive FDA 510(k) clearance?

RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER received FDA 510(k) clearance on 2013-05-24, under 510(k) number K130911.

Who is the listed applicant for RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER?

The FDA 510(k) record lists Ev3, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER?

The FDA product code for RAPIDCROSS PTA RAPID EXCHANGE BALLOON 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Ev3, 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.

K132777NANOCROSS ELITE .14 OVER-THE-WIRE PTA, BALLOON DILATION CATHETERK123544RAPIDCROSS PTA RAPID EXCHANGE, BALLOON DILATATION CATHETERK111010SPIDERFX EMBOLIC PROTECTION DEVICEK111723TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEMK111490MARKSMAN CATHETER, *REFERS TO DIFFERENT CATHETER WORKING LENGHTS, DISTAL SINGLE COILED LENGTHS AND DISTAL SHAFT LENGTHSK110319EVERCROSS 0.035 OTW PTA DILATATION CATHETER

View all 34 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.

K260416ZYLOX Hippo PTA Balloon Dilatation CatheterZylox Medtech Co., Ltd.K254212NC PTA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.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.

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.

↑