RX Viatrac 14 Peripheral Dilatation Catheter, Model #'S 1003006-20, 1003007-20, 1003008-20, 1003009-20, 1003010-20, 1003

Q: What is the product code of K983055?

The FDA product code is LIT – Catheter, Angioplasty, Peripheral, Transluminal, a Class II (moderate risk) device regulated under 21 CFR 870.1250.

FDA 510(k) K983055 · Guidant Corp.

Substantially Equivalent

510(k) numberK983055

Submission

Device name: RX Viatrac 14 Peripheral Dilatation Catheter, Model #'S 1003006-20, 1003007-20, 1003008-20, 1003009-20, 1003010-20, 1003
Applicant: Guidant Corp.
Santa Clara, CA, US
Received: September 1, 1998
Decision date: December 30, 1998
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: LIT – Catheter, Angioplasty, Peripheral, Transluminal
Device class: Class II (moderate risk)
Regulation: 21 CFR 870.1250
Specialty: Cardiovascular

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K242419	018 Hydrophilic Coated OTW PTA Balloon Dilatation CatheterLIT · Traditional	Creagh Medical Ltd. Dba Surmodics, Inc.	11/15/2024SE
K241740	Finesse Injectable PTA Balloon Dilatation CatheterLIT · Special	Summa Therapeutics	07/16/2024SE
K241711	Oscar Peripheral Multifunctional Catheter systemLIT · Special	Biotronik, Inc.	07/11/2024SE
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Questions and answers

When was RX Viatrac 14 Peripheral Dilatation Catheter, Model #'S 1003006-20, 1003007-20, 1003008-20, 1003009-20, 1003010-20, 1003 cleared by the FDA?

RX Viatrac 14 Peripheral Dilatation Catheter, Model #'S 1003006-20, 1003007-20, 1003008-20, 1003009-20, 1003010-20, 1003 (K983055) received a 510(k) decision of Substantially Equivalent on December 30, 1998, 120 days after the submission was received.

What is the product code of K983055?

The FDA product code is LIT – Catheter, Angioplasty, Peripheral, Transluminal, a Class II (moderate risk) device regulated under 21 CFR 870.1250.