510(k) K011349
K011349 is an FDA 510(k) premarket notification submitted by Medcanica, Inc. for the device "INTERCOSTAL LOCKABLE-DIRECTABLE PORT". The FDA issued a decision of Substantially Equivalent on October 5, 2001. The device falls under product code DRC (Trocar), a Class II device regulated under 21 CFR 870.1390. Medcanica, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 5, 2001
- Date Received
- May 2, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Trocar
- Device Class
- Class II
- Regulation Number
- 870.1390
- Review Panel
- CV
- Submission Type