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FDA 510(k)

VASCOSCREW 6/60 AND VASCOSCREW 8/60

K-Number: K914121 · 1993-08-24

ApplicantVascor Medical Corp.
Decision Date1993-08-24
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VASCOSCREW 6/60 AND VASCOSCREW 8/60 is the device name listed in this FDA 510(k) record. The listed applicant is Vascor Medical Corp.. It received FDA 510(k) clearance on 1993-08-24 under 510(k) number K914121. The device is classified under product code DTB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VASCOSCREW 6/60 AND VASCOSCREW 8/60?

VASCOSCREW 6/60 AND VASCOSCREW 8/60 is a medical device that received FDA 510(k) clearance on 1993-08-24. The listed applicant is Vascor Medical Corp.. The 510(k) number is K914121.

When did VASCOSCREW 6/60 AND VASCOSCREW 8/60 receive FDA 510(k) clearance?

VASCOSCREW 6/60 AND VASCOSCREW 8/60 received FDA 510(k) clearance on 1993-08-24, under 510(k) number K914121.

Who is the listed applicant for VASCOSCREW 6/60 AND VASCOSCREW 8/60?

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

What is the FDA product code for VASCOSCREW 6/60 AND VASCOSCREW 8/60?

The FDA product code for VASCOSCREW 6/60 AND VASCOSCREW 8/60 is DTB.

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 Vascor 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.

K920662VASCOTWIST 9/60K913831VASCO TIP/VASCOFLANGE

Related Devices (Code: DTB)

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.

K061212BIOTRONIK ENDOCARDIAL PACING LEADSBiotronik, Inc.K041809PERMANENT PACING LEAD, MODEL PY2Oscor, Inc.K040569PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJUOscor, Inc.K031274MODEL 5071 MYOCARDIAL PACING LEADMedtronic VascularK031210MODEL 4951M MYOCARDIAL UNIPOLAR LEADMetronic, Inc.K023205ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BPBiotronik, Inc.

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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