Medi-Tech Platform Guide Catheter
FDA 510(k) K952345 · Medi-Tech, Inc.
510(k) numberK952345
Submission
- Device name
- Medi-Tech Platform Guide Catheter
- Applicant
- Medi-Tech, Inc.
Maple Grove, MN, US - Received
- May 19, 1995
- Decision date
- August 17, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQY – Catheter, Percutaneous
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
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| K942552 | Therapeutic Drug Monitoring Control, UnassayedDIF · Traditional | 09/09/1994SE |
| K904073 | Coagulation Reference Plasma, AbnormalGGC · Traditional | 10/22/1990SE |
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Questions and answers
When was Medi-Tech Platform Guide Catheter cleared by the FDA?
Medi-Tech Platform Guide Catheter (K952345) received a 510(k) decision of Substantially Equivalent on August 17, 1995, 90 days after the submission was received.
What is the product code of K952345?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.