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FDA 510(k)

LAB-SITE SAFETY NEEDLE

K-Number: K905018 · 1991-01-16

ApplicantTelos Medical Corp.
Decision Date1991-01-16
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LAB-SITE SAFETY NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Telos Medical Corp.. It received FDA 510(k) clearance on 1991-01-16 under 510(k) number K905018. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LAB-SITE SAFETY NEEDLE?

LAB-SITE SAFETY NEEDLE is a medical device that received FDA 510(k) clearance on 1991-01-16. The listed applicant is Telos Medical Corp.. The 510(k) number is K905018.

When did LAB-SITE SAFETY NEEDLE receive FDA 510(k) clearance?

LAB-SITE SAFETY NEEDLE received FDA 510(k) clearance on 1991-01-16, under 510(k) number K905018.

Who is the listed applicant for LAB-SITE SAFETY NEEDLE?

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

What is the FDA product code for LAB-SITE SAFETY NEEDLE?

The FDA product code for LAB-SITE SAFETY NEEDLE is DQO.

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.

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Other records listing Telos Medical Corp. 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.

K920375DISPOSABLE INTRAUTERINE PRESSURE TRANSDUCERK920044DUAL LUMEN TRANSCERIVICAL INTRAUTERINE KITK914387TRANSCERVICAL INTRAUTERINE KITK905017LAB-SITEK882224ULTRANS DISPOSABLE INTRAUTERINEK883832CATHETER, INTRAUTERINE AND INTRODUCER

View all 7 devices →

Related Devices (Code: DQO)

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.

K261455Arterial Pressure Monitoring Set/TraySpectrum VascularK252702Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602NBioptimal International Pte. , Ltd.K254278Arterial Pressure Monitoring Set/TraySpectrum VascularK250751DualView CatheterTerumo CorporationK242966Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterGentuity, LLCK242420pNOVUS 21 MicrocatheterPhenox, 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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