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FDA 510(k)

TRUE DILATATION PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER, 20MM X 4.5CM, TRUE DILATATION PERCUTANEOUS TRANSLUMINA

K-Number: K121083 · 2012-10-11

ApplicantLoma Vista Medical
Decision Date2012-10-11
Product CodeOZT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TRUE DILATATION PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER, 20MM X 4.5CM, TRUE DILATATION PERCUTANEOUS TRANSLUMINA is the device name listed in this FDA 510(k) record. The listed applicant is Loma Vista Medical. It received FDA 510(k) clearance on 2012-10-11 under 510(k) number K121083. The device is classified under product code OZT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRUE DILATATION PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER, 20MM X 4.5CM, TRUE DILATATION PERCUTANEOUS TRANSLUMINA?

TRUE DILATATION PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER, 20MM X 4.5CM, TRUE DILATATION PERCUTANEOUS TRANSLUMINA is a medical device that received FDA 510(k) clearance on 2012-10-11. The listed applicant is Loma Vista Medical. The 510(k) number is K121083.

When did TRUE DILATATION PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER, 20MM X 4.5CM, TRUE DILATATION PERCUTANEOUS TRANSLUMINA receive FDA 510(k) clearance?

TRUE DILATATION PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER, 20MM X 4.5CM, TRUE DILATATION PERCUTANEOUS TRANSLUMINA received FDA 510(k) clearance on 2012-10-11, under 510(k) number K121083.

Who is the listed applicant for TRUE DILATATION PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER, 20MM X 4.5CM, TRUE DILATATION PERCUTANEOUS TRANSLUMINA?

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

What is the FDA product code for TRUE DILATATION PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER, 20MM X 4.5CM, TRUE DILATATION PERCUTANEOUS TRANSLUMINA?

The FDA product code for TRUE DILATATION PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER, 20MM X 4.5CM, TRUE DILATATION PERCUTANEOUS TRANSLUMINA is OZT.

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Related Devices (Code: OZT)

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.

K253855KardiaPSI Balloon CatheterIntervention Tech, Inc. ; dba CorventionK260437Valvuloplasty Balloon Catheter (ValvuloPro)Dongguan TT Medical, Inc.K241562OutFlo Aortic Valve Dilatation Balloon CatheterDisa MedinotecK240967ValvuloPro Valvuloplasty Balloon CatheterDongguan TT Medical, Inc.K231814ValvuloPro Valvuloplasty Balloon CatheterDongguan TT Medical, Inc.K220881INOUE BALLOON AToray Industries, Inc.

Official Source

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