Question 1

Who is the manufacturer of SHERPA SHERPA II AND ASCENT CORONARY GUIDING CATHETERS?

Accepted Answer

Medtronics Interventional Vascular filed the 510(k) submission for SHERPA SHERPA II AND ASCENT CORONARY GUIDING CATHETERS (K944668).

Question 2

What is the FDA product code for SHERPA SHERPA II AND ASCENT CORONARY GUIDING CATHETERS?

Accepted Answer

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

Question 3

When was SHERPA SHERPA II AND ASCENT CORONARY GUIDING CATHETERS cleared by the FDA?

Accepted Answer

Mar 3, 1995 (decision: SESE).

Question 4

What is the regulatory pathway for SHERPA SHERPA II AND ASCENT CORONARY GUIDING CATHETERS?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like SHERPA SHERPA II AND ASCENT CORONARY GUIDING CATHETERS?

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	K944668
Device Name	SHERPA SHERPA II AND ASCENT CORONARY GUIDING CATHETERS
Applicant	Medtronics Interventional Vascular
Product Code	DQY · Cardiovascular
Decision Date	Mar 3, 1995
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1250
Device Class	Class 2

SHERPA SHERPA II AND ASCENT CORONARY GUIDING CATHETERS

Device Facts

Regulatory Classification

Identification