510(k) K831636
K831636 is an FDA 510(k) premarket notification submitted by Accu-Line for the device "PERCUTANEOUS INTRODUCER KIT". The FDA issued a decision of Substantially Equivalent on August 24, 1983. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Accu-Line has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 24, 1983
- Date Received
- May 23, 1983
- 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