Multicath - Code#S 8.1207.OO/8.1208.00/8.1205.20
FDA 510(k) K870067 · Vygon Corp.
510(k) numberK870067
Submission
- Device name
- Multicath - Code#S 8.1207.OO/8.1208.00/8.1205.20
- Applicant
- Vygon Corp.
East Rutherford, NJ, US - Received
- January 8, 1987
- Decision date
- April 28, 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 Multicath - Code#S 8.1207.OO/8.1208.00/8.1205.20 cleared by the FDA?
Multicath - Code#S 8.1207.OO/8.1208.00/8.1205.20 (K870067) received a 510(k) decision of Substantially Equivalent on April 28, 1987, 110 days after the submission was received.
What is the product code of K870067?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.