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)

EXEL SECURE TOUCH SAFETY (P.S.V.) SCALP VEIN SET

K-Number: K010197 · 2001-05-14

ApplicantExelint International, Co.
Decision Date2001-05-14
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

EXEL SECURE TOUCH SAFETY (P.S.V.) SCALP VEIN SET is the device name listed in this FDA 510(k) record. The listed applicant is Exelint International, Co.. It received FDA 510(k) clearance on 2001-05-14 under 510(k) number K010197. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXEL SECURE TOUCH SAFETY (P.S.V.) SCALP VEIN SET?

EXEL SECURE TOUCH SAFETY (P.S.V.) SCALP VEIN SET is a medical device that received FDA 510(k) clearance on 2001-05-14. The listed applicant is Exelint International, Co.. The 510(k) number is K010197.

When did EXEL SECURE TOUCH SAFETY (P.S.V.) SCALP VEIN SET receive FDA 510(k) clearance?

EXEL SECURE TOUCH SAFETY (P.S.V.) SCALP VEIN SET received FDA 510(k) clearance on 2001-05-14, under 510(k) number K010197.

Who is the listed applicant for EXEL SECURE TOUCH SAFETY (P.S.V.) SCALP VEIN SET?

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

What is the FDA product code for EXEL SECURE TOUCH SAFETY (P.S.V.) SCALP VEIN SET?

The FDA product code for EXEL SECURE TOUCH SAFETY (P.S.V.) SCALP VEIN SET is FPA.

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 Exelint International, Co. 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.

K251089EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe with Secure Touch® Safety Needle; EXEL Disposable Hypodermic NeedleK101309EXELINT ALUMINUM HUB BLUNT NEEDLESK020189EXEL BUTTERFLY SCALP VEIN SETK003627EXEL SECURE TOUCH SAFETY A.V. FISTULA NEEDLE SETK001496A.V. FISTULA NEEDLE

Related Devices (Code: FPA)

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.

K254123Ecomed Disposable Administration SetsEcomed Solutions, LLCK261530iiSure Infusion SetDeka Research and DevelopmentK252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)Amsino International, Inc.K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc.K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]Np MedicalK250325BD Alaris Pump Infusion SetCarefusion (Bd)

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.

↑