510(k) K923487
K923487 is an FDA 510(k) premarket notification submitted by Ballard Medical Products for the device "BAL CATH". The FDA issued a decision of Substantially Equivalent (kit) on July 30, 1993. The device falls under product code KTR (Tube, Aspirating, Bronchoscope, Rigid), a Class II device regulated under 21 CFR 874.4680. Ballard Medical Products has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- July 30, 1993
- Date Received
- July 15, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tube, Aspirating, Bronchoscope, Rigid
- Device Class
- Class II
- Regulation Number
- 874.4680
- Review Panel
- EN
- Submission Type
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).