510(k) K943622
K943622 is an FDA 510(k) premarket notification submitted by Boston Scientific Scimed, Inc. for the device "SCHNEIDER PINK POWER SOFTIP GUIDNIG CATHETER". The FDA issued a decision of Substantially Equivalent on Nov 30, 1994. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Boston Scientific Scimed, Inc. has 34 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 30, 1994
- Date Received
- Jul 27, 1994
- 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
- 510(k)