Question 1

Who is the manufacturer of PROFLEX 5?

Accepted Answer

Peripheral Systems Group filed the 510(k) submission for PROFLEX 5 (K915168).

Question 2

What is the FDA product code for PROFLEX 5?

Accepted Answer

LIT. It is classified under 21 CFR 870.1250 as a Class 2 device in the Cardiovascular panel.

Question 3

When was PROFLEX 5 cleared by the FDA?

Accepted Answer

Feb 19, 1992 (decision: SESE).

Question 4

What is the regulatory pathway for PROFLEX 5?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like PROFLEX 5?

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	K915168
Device Name	PROFLEX 5
Applicant	Peripheral Systems Group
Product Code	LIT · Cardiovascular
Decision Date	Feb 19, 1992
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1250
Device Class	Class 2

PROFLEX 5

Device Facts

Regulatory Classification

Identification