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FDA 510(k)

MODELS 6526,6527,6528 PERCU. TRANS. ANGIO. CATH.

K-Number: K891611 · 1989-06-12

ApplicantMedtronic Versaflex, Inc.
Decision Date1989-06-12
Product CodeLJT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MODELS 6526,6527,6528 PERCU. TRANS. ANGIO. CATH. is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Versaflex, Inc.. It received FDA 510(k) clearance on 1989-06-12 under 510(k) number K891611. The device is classified under product code LJT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODELS 6526,6527,6528 PERCU. TRANS. ANGIO. CATH.?

MODELS 6526,6527,6528 PERCU. TRANS. ANGIO. CATH. is a medical device that received FDA 510(k) clearance on 1989-06-12. The listed applicant is Medtronic Versaflex, Inc.. The 510(k) number is K891611.

When did MODELS 6526,6527,6528 PERCU. TRANS. ANGIO. CATH. receive FDA 510(k) clearance?

MODELS 6526,6527,6528 PERCU. TRANS. ANGIO. CATH. received FDA 510(k) clearance on 1989-06-12, under 510(k) number K891611.

Who is the listed applicant for MODELS 6526,6527,6528 PERCU. TRANS. ANGIO. CATH.?

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

What is the FDA product code for MODELS 6526,6527,6528 PERCU. TRANS. ANGIO. CATH.?

The FDA product code for MODELS 6526,6527,6528 PERCU. TRANS. ANGIO. CATH. is LJT.

Related Clinical Trials

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Other records listing Medtronic Versaflex, 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.

K890898MODEL 611101 CONTRAST INJECTION DEVICE

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Official Source

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