510(k) K991601
K991601 is an FDA 510(k) premarket notification submitted by Endologix, Inc. for the device "DUAL LUMEN CATHETER, MODEL DL-35-90". The FDA issued a decision of Substantially Equivalent on October 28, 1999. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Endologix, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 28, 1999
- Date Received
- May 10, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Percutaneous
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type