Arrow Vessel Catheter. Kit W/20GA Indwel
FDA 510(k) K810962 · Arrow Intl., Inc.
510(k) numberK810962
Submission
- Device name
- Arrow Vessel Catheter. Kit W/20GA Indwel
- Applicant
- Arrow Intl., Inc.
Walker, MI, US - Received
- April 8, 1981
- Decision date
- April 29, 1981
- 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 Arrow Vessel Catheter. Kit W/20GA Indwel cleared by the FDA?
Arrow Vessel Catheter. Kit W/20GA Indwel (K810962) received a 510(k) decision of Substantially Equivalent on April 29, 1981, 21 days after the submission was received.
What is the product code of K810962?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.