Question 1

Who is the manufacturer of SARNS SAFETY LOOP?

Accepted Answer

3M Health Care, Sarns filed the 510(k) submission for SARNS SAFETY LOOP (K863593).

Question 2

What is the FDA product code for SARNS SAFETY LOOP?

Accepted Answer

DWD. It is classified under 21 CFR 870.4430 as a Class 2 device in the Cardiovascular panel.

Question 3

When was SARNS SAFETY LOOP cleared by the FDA?

Accepted Answer

Nov 18, 1986 (decision: SESE).

Question 4

What is the regulatory pathway for SARNS SAFETY LOOP?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like SARNS SAFETY LOOP?

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	K863593
Device Name	SARNS SAFETY LOOP
Applicant	3M Health Care, Sarns
Product Code	DWD · Cardiovascular
Decision Date	Nov 18, 1986
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.4430
Device Class	Class 2

SARNS SAFETY LOOP

Device Facts

Regulatory Classification

Identification

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