Question 1

Who is the manufacturer of SMARTNEEDLE(R) OVER-THE-NEEDLE CATHETER?

Accepted Answer

Peripheral Systems Group filed the 510(k) submission for SMARTNEEDLE(R) OVER-THE-NEEDLE CATHETER (K932777).

Question 2

What is the FDA product code for SMARTNEEDLE(R) OVER-THE-NEEDLE CATHETER?

Accepted Answer

ITX. It is classified under 21 CFR 892.1570 as a Class 2 device in the Radiology panel.

Question 3

When was SMARTNEEDLE(R) OVER-THE-NEEDLE CATHETER cleared by the FDA?

Accepted Answer

Oct 7, 1993 (decision: SESE).

Question 4

What is the regulatory pathway for SMARTNEEDLE(R) OVER-THE-NEEDLE CATHETER?

Accepted Answer

510(k) clearance (submission type: Traditional).

Question 5

Who can help prepare an FDA 510(k) submission like SMARTNEEDLE(R) OVER-THE-NEEDLE CATHETER?

Accepted Answer

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Record ID	K932777
Device Name	SMARTNEEDLE(R) OVER-THE-NEEDLE CATHETER
Applicant	Peripheral Systems Group
Product Code	ITX · Radiology
Decision Date	Oct 7, 1993
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1570
Device Class	Class 2

SMARTNEEDLE(R) OVER-THE-NEEDLE CATHETER

Device Facts

Regulatory Classification

Identification