Radial Artery Catherization Set with Integral Needle Protection,Model RA-04020-SP
FDA 510(k) K021120 · Arrow Intl., Inc.
510(k) numberK021120
Submission
- Device name
- Radial Artery Catherization Set with Integral Needle Protection,Model RA-04020-SP
- Applicant
- Arrow Intl., Inc.
Reading, PA, US - Received
- April 8, 2002
- Decision date
- May 2, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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Questions and answers
When was Radial Artery Catherization Set with Integral Needle Protection,Model RA-04020-SP cleared by the FDA?
Radial Artery Catherization Set with Integral Needle Protection,Model RA-04020-SP (K021120) received a 510(k) decision of Substantially Equivalent on May 2, 2002, 24 days after the submission was received.
What is the product code of K021120?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.