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FDA 510(k)

0.014 FLOPPY & 0.014 INTERMEDIATE GUIDE WIRES W/PHOSPHORYLCHOLINE POLYMER COATING & 4CM RADIOPAQUE TIP

K-Number: K961232 · 1996-06-26

ApplicantBiocompatibles , Ltd.
Decision Date1996-06-26
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

0.014 FLOPPY & 0.014 INTERMEDIATE GUIDE WIRES W/PHOSPHORYLCHOLINE POLYMER COATING & 4CM RADIOPAQUE TIP is the device name listed in this FDA 510(k) record. The listed applicant is Biocompatibles , Ltd.. It received FDA 510(k) clearance on 1996-06-26 under 510(k) number K961232. 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 0.014 FLOPPY & 0.014 INTERMEDIATE GUIDE WIRES W/PHOSPHORYLCHOLINE POLYMER COATING & 4CM RADIOPAQUE TIP?

0.014 FLOPPY & 0.014 INTERMEDIATE GUIDE WIRES W/PHOSPHORYLCHOLINE POLYMER COATING & 4CM RADIOPAQUE TIP is a medical device that received FDA 510(k) clearance on 1996-06-26. The listed applicant is Biocompatibles , Ltd.. The 510(k) number is K961232.

When did 0.014 FLOPPY & 0.014 INTERMEDIATE GUIDE WIRES W/PHOSPHORYLCHOLINE POLYMER COATING & 4CM RADIOPAQUE TIP receive FDA 510(k) clearance?

0.014 FLOPPY & 0.014 INTERMEDIATE GUIDE WIRES W/PHOSPHORYLCHOLINE POLYMER COATING & 4CM RADIOPAQUE TIP received FDA 510(k) clearance on 1996-06-26, under 510(k) number K961232.

Who is the listed applicant for 0.014 FLOPPY & 0.014 INTERMEDIATE GUIDE WIRES W/PHOSPHORYLCHOLINE POLYMER COATING & 4CM RADIOPAQUE TIP?

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

What is the FDA product code for 0.014 FLOPPY & 0.014 INTERMEDIATE GUIDE WIRES W/PHOSPHORYLCHOLINE POLYMER COATING & 4CM RADIOPAQUE TIP?

The FDA product code for 0.014 FLOPPY & 0.014 INTERMEDIATE GUIDE WIRES W/PHOSPHORYLCHOLINE POLYMER COATING & 4CM RADIOPAQUE TIP 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 Biocompatibles , Ltd. 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.

K9551350.014 INTERMEDIATE GUIDE WIRE W/PHOSPHORYLCHOLINE POLYMER COATINGK952152PROCLEAR DAILY WEAR CONTACT LENS

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.

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