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)

MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIRE

K-Number: K043398 · 2005-03-01

ApplicantNeometrics, Inc.
Decision Date2005-03-01
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIRE is the device name listed in this FDA 510(k) record. The listed applicant is Neometrics, Inc.. It received FDA 510(k) clearance on 2005-03-01 under 510(k) number K043398. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIRE?

MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIRE is a medical device that received FDA 510(k) clearance on 2005-03-01. The listed applicant is Neometrics, Inc.. The 510(k) number is K043398.

When did MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIRE receive FDA 510(k) clearance?

MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIRE received FDA 510(k) clearance on 2005-03-01, under 510(k) number K043398.

Who is the listed applicant for MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIRE?

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

What is the FDA product code for MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIRE?

The FDA product code for MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIRE is DQX.

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 Neometrics, 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.

K123439NEO ERCP GUIDEWIREK101729NEOWIRE PTA/PTCA GUIDEWIREK070150VASCUPUNCTURE PICC GUIDEWIREK040786VASCUPUNCTURE PICC GUIDEWIRE WITH HYDRO-SILK COATINGK033321SELECTIVA SB GUIDEWIREK031652VASCUPUNCTURE PICC GUIDEWIRE

View all 17 devices →

Related Devices (Code: DQX)

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.

K253146Hyperdrive 35 GuidewireRapid-Medical , Ltd.K261281CROSSLEAD Standard 035 and CROSSLEAD Stiff 035Filmecc Co., Ltd.K253667Accoat Guide WireSp Medical A/SK261640Merit MAK Nitinol/Gold-Tungsten Guide WireMerit Medical Ireland , Ltd.K254137InQwire Amplatz Guide WireMerit Medical Ireland, Ltd.K260544FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40FMD Co., 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.

↑