510(k) K864535
K864535 is an FDA 510(k) premarket notification submitted by Concord Laboratories, Inc. for the device "TRACHEOBRONCHIAL SUCTION CATHETER, CAT. NO. 6110". The FDA issued a decision of Substantially Equivalent on January 6, 1987. The device falls under product code BSY (Catheters, Suction, Tracheobronchial), a Class I device regulated under 21 CFR 868.6810. Concord Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 6, 1987
- Date Received
- November 17, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheters, Suction, Tracheobronchial
- Device Class
- Class I
- Regulation Number
- 868.6810
- Review Panel
- AN
- Submission Type