510(k) K781772
K781772 is an FDA 510(k) premarket notification submitted by Medi-Tech, Inc. for the device "CATHETER, TRANSLUMINAL BALLOON". The FDA issued a decision of Substantially Equivalent on March 6, 1979. The device falls under product code GBA (Catheter, Balloon Type), a Class I device regulated under 21 CFR 878.4200. Medi-Tech, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 6, 1979
- Date Received
- October 16, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Balloon Type
- Device Class
- Class I
- Regulation Number
- 878.4200
- Review Panel
- SU
- Submission Type