Medi-Trace

FDA 510(k) K811410 · Graphic Controls Corp.

Substantially Equivalent

510(k) numberK811410

Submission

Device name
Medi-Trace
Applicant
Graphic Controls Corp.
Mchenry, IL, US
Received
May 19, 1981
Decision date
June 12, 1981
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KRA – Catheter, Continuous Flush
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1210
Specialty
Cardiovascular

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K231821XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S…KRA · Traditional Transit Scientific, LLC11/29/2023SE
K231279Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mmKRA · Traditional Ablative Solutions, Inc.07/05/2023SE
K231148ScleroSafe™ 150 mm, ScleroSafe™ 350 mmKRA · Traditional Vvt Medical , Ltd.06/20/2023SE
K230957TriSalus TriNav® LV Infusion SystemKRA · Traditional Trisalus Life Sciences05/02/2023SE
K223139Wallaby 017 Micro CatheterKRA · Traditional Wallaby Medical04/25/2023SE

More from Wallaby Medical

510(k)DeviceDecision
K981964Medi-Trace 4103 Neonatal ElectrodeDRX · Traditional 11/13/1998SE
K983287Medi-Trace 1610C Combination Defibrillation, Monitoring and Pacing ElectrodeMKJ · Traditional 11/05/1998SE
K974730Softrans Plus Intrauterine Pressure Catheter System (Iup 5000, Softrans Plus Iupc)KXO · Traditional 07/14/1998SE
K980857Medi-Trace 1310P Combination Defibrillation, Monitoring & Pacing ElectrodeMKJ · Traditional 05/12/1998SE
K972970Medi-Trace 1510M Combination Defibrillation, Monitoring and Pacing ElectrodeMKJ · Traditional 08/27/1997SE
K964387Point of Use II Sharps-A-GatorMMK · Traditional 03/27/1997SE
K964279Softrans Intrauterine Pressure Catheter System (Iup 4000 Softrans Iupc)KXO · Traditional 01/22/1997SE
K963151Medi-Trace 5700 Resting ECG ElectrodeDRX · Traditional 11/19/1996SE
K963038Medi-Trace 3600 Series of ECG Monitoring ElectrodeDRX · Traditional 11/15/1996SE
K960968Medi-Trace 200, Medi-Trace 200-30DRX · Traditional 10/28/1996SE

Questions and answers

When was Medi-Trace cleared by the FDA?

Medi-Trace (K811410) received a 510(k) decision of Substantially Equivalent on June 12, 1981, 24 days after the submission was received.

What is the product code of K811410?

The FDA product code is KRA – Catheter, Continuous Flush, a Class II (moderate risk) device regulated under 21 CFR 870.1210.