510(k) K971320
K971320 is an FDA 510(k) premarket notification submitted by Boston Scientific Corp for the device "CRE BALLOON DILATATION CATHETER". The FDA issued a decision of Substantially Equivalent on October 9, 1997. The device falls under product code KNQ (Dilator, Esophageal), a Class II device regulated under 21 CFR 876.5365. Boston Scientific Corp has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 9, 1997
- Date Received
- April 10, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dilator, Esophageal
- Device Class
- Class II
- Regulation Number
- 876.5365
- Review Panel
- GU
- Submission Type