Intercostal Lockable-Directable Port

FDA 510(k) K011349 · Medcanica, Inc.

Substantially Equivalent

510(k) numberK011349

Submission

Device name
Intercostal Lockable-Directable Port
Applicant
Medcanica, Inc.
Miami, FL, US
Received
May 2, 2001
Decision date
October 5, 2001
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DRC – Trocar
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1390
Specialty
Cardiovascular

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Questions and answers

When was Intercostal Lockable-Directable Port cleared by the FDA?

Intercostal Lockable-Directable Port (K011349) received a 510(k) decision of Substantially Equivalent on October 5, 2001, 156 days after the submission was received.

What is the product code of K011349?

The FDA product code is DRC – Trocar, a Class II (moderate risk) device regulated under 21 CFR 870.1390.