Direct Antibiotic Infusion Kit

FDA 510(k) K113043 · Summit Medical Products, Inc.

Substantially Equivalent

510(k) numberK113043

Submission

Device name
Direct Antibiotic Infusion Kit
Applicant
Summit Medical Products, Inc.
Salt Lake Cty, UT, US
Received
October 13, 2011
Decision date
December 20, 2011
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LJS – Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5970
Specialty
General Hospital
Implant
Yes

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K241587pilot TLSLJS · Traditional Vygon Corporation02/26/2025SE
K241910Neonav ECG Tip Location SystemLJS · Traditional Navi Medical Technologies01/19/2025SE
K243941HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001201)…LJS · Special Access Vascular, Inc.01/17/2025SE
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More from Piccolo Medical, Inc.

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Questions and answers

When was Direct Antibiotic Infusion Kit cleared by the FDA?

Direct Antibiotic Infusion Kit (K113043) received a 510(k) decision of Substantially Equivalent on December 20, 2011, 68 days after the submission was received.

What is the product code of K113043?

The FDA product code is LJS – Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days, a Class II (moderate risk) device regulated under 21 CFR 880.5970.