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)

MODIFIED SCHNEIDER-SHILEY WIRE TORQUER

K-Number: K875323 · 1988-03-28

ApplicantSchneider-Shilley (Usa)
Decision Date1988-03-28
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFIED SCHNEIDER-SHILEY WIRE TORQUER is the device name listed in this FDA 510(k) record. The listed applicant is Schneider-Shilley (Usa). It received FDA 510(k) clearance on 1988-03-28 under 510(k) number K875323. 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 MODIFIED SCHNEIDER-SHILEY WIRE TORQUER?

MODIFIED SCHNEIDER-SHILEY WIRE TORQUER is a medical device that received FDA 510(k) clearance on 1988-03-28. The listed applicant is Schneider-Shilley (Usa). The 510(k) number is K875323.

When did MODIFIED SCHNEIDER-SHILEY WIRE TORQUER receive FDA 510(k) clearance?

MODIFIED SCHNEIDER-SHILEY WIRE TORQUER received FDA 510(k) clearance on 1988-03-28, under 510(k) number K875323.

Who is the listed applicant for MODIFIED SCHNEIDER-SHILEY WIRE TORQUER?

The FDA 510(k) record lists Schneider-Shilley (Usa) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFIED SCHNEIDER-SHILEY WIRE TORQUER?

The FDA product code for MODIFIED SCHNEIDER-SHILEY WIRE TORQUER 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 Schneider-Shilley (Usa) 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.

K882826SOFTRAC-PTA PERIPHERAL DILATATION CATHETERK875175MODIFIED PERIPHERAL DILATATION CATHETERSK881197SOFTRAC-PTA(TM) PERIPHERAL DILATATION CATHETERK875322MODIFIED SCHNEIDER-SHILEY PRESSURE MANOMETERK875327MODIFIED SELDINGER INITIAL PUNCTURE INSTRUMENTK875324MODIFIED SCHNEIDER SHILEY INFLATION SYRINGES

View all 9 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.

↑