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)

BMC COAXIAL INJECTABLE CATHETER, MODEL CIC 38/145 AND CIC 35/145

K-Number: K014075 · 2002-03-07

ApplicantBaylis Medical Co., Inc.
Decision Date2002-03-07
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BMC COAXIAL INJECTABLE CATHETER, MODEL CIC 38/145 AND CIC 35/145 is the device name listed in this FDA 510(k) record. The listed applicant is Baylis Medical Co., Inc.. It received FDA 510(k) clearance on 2002-03-07 under 510(k) number K014075. 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 BMC COAXIAL INJECTABLE CATHETER, MODEL CIC 38/145 AND CIC 35/145?

BMC COAXIAL INJECTABLE CATHETER, MODEL CIC 38/145 AND CIC 35/145 is a medical device that received FDA 510(k) clearance on 2002-03-07. The listed applicant is Baylis Medical Co., Inc.. The 510(k) number is K014075.

When did BMC COAXIAL INJECTABLE CATHETER, MODEL CIC 38/145 AND CIC 35/145 receive FDA 510(k) clearance?

BMC COAXIAL INJECTABLE CATHETER, MODEL CIC 38/145 AND CIC 35/145 received FDA 510(k) clearance on 2002-03-07, under 510(k) number K014075.

Who is the listed applicant for BMC COAXIAL INJECTABLE CATHETER, MODEL CIC 38/145 AND CIC 35/145?

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

What is the FDA product code for BMC COAXIAL INJECTABLE CATHETER, MODEL CIC 38/145 AND CIC 35/145?

The FDA product code for BMC COAXIAL INJECTABLE CATHETER, MODEL CIC 38/145 AND CIC 35/145 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 Baylis Medical Co., 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.

K122926SUREFLEX STEERABLE GUIDING SHEATH KITK111523OSTEOCOOL (TM) RF ABLATION SYSTEMK102948TORFLEX TRANSSEPTAL GUIDING SHEATHK102192INDISCAL DIGITAL MANOMETERK101372DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20K101615POWERWIRE RADIOFREQUENCY GUIDEWIRE

View all 28 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.

↑