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)

PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS

K-Number: K011557 · 2001-07-12

ApplicantNuMED, Inc.
Decision Date2001-07-12
Product CodeDXF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS is the device name listed in this FDA 510(k) record. The listed applicant is NuMED, Inc.. It received FDA 510(k) clearance on 2001-07-12 under 510(k) number K011557. The device is classified under product code DXF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS?

PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS is a medical device that received FDA 510(k) clearance on 2001-07-12. The listed applicant is NuMED, Inc.. The 510(k) number is K011557.

When did PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS receive FDA 510(k) clearance?

PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS received FDA 510(k) clearance on 2001-07-12, under 510(k) number K011557.

Who is the listed applicant for PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS?

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

What is the FDA product code for PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS?

The FDA product code for PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS is DXF.

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 NuMED, 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.

K213915BIB Stent Placement CatheterK211910Z-6 Atrioseptostomy CatheterK211134BIB Stent Placement CatheterK190974D'Vill IntroducerK171206D'Vill IntroducerK161451BIB Stent Placement Catheter

View all 48 devices →

Related Devices (Code: DXF)

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.

K261745LightningWire Transseptal Puncture System (TPS)ElectroWire MedicalK253799SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R)Pressure Products Medical Device Manufacturing, LLCK260292HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)Atraverse MedicalK252419HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)Atraverse Medical, Inc.K251007CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F)Circa Scientific, Inc.K243193Cross Wise™ Multi-Use RF Adapter CableCirca Scientific, 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.

↑