Medi-Tech Selective Torque Catheter
FDA 510(k) K864118 · Medi-Tech, Inc.
510(k) numberK864118
Submission
- Device name
- Medi-Tech Selective Torque Catheter
- Applicant
- Medi-Tech, Inc.
Watertown, MA, US - Received
- October 21, 1986
- Decision date
- April 9, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DQY – Catheter, Percutaneous
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
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Questions and answers
When was Medi-Tech Selective Torque Catheter cleared by the FDA?
Medi-Tech Selective Torque Catheter (K864118) received a 510(k) decision of Substantially Equivalent on April 9, 1987, 170 days after the submission was received.
What is the product code of K864118?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.