Catheter, Arterial Line
FDA 510(k) K790083 · Namic
510(k) numberK790083
Submission
- Device name
- Catheter, Arterial Line
- Applicant
- Namic
Mchenry, IL, US - Received
- January 12, 1979
- Decision date
- January 25, 1979
- 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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|---|---|---|
| K953676 | Breeze Digital Inflation DeviceMAV · Traditional | 03/29/1996SE |
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| K822100 | High Pressure Contrast Injection LineDQO · Traditional | 08/24/1982SE |
| K813549 | Continuous Flush DeviceDRS · Traditional | 01/12/1982SE |
| K790082 | Arterial Extension SetDQO · Traditional | 01/25/1979SE |
| K782095 | Stopcocks, ManifoldsDTL · Traditional | 01/23/1979SE |
Questions and answers
When was Catheter, Arterial Line cleared by the FDA?
Catheter, Arterial Line (K790083) received a 510(k) decision of Substantially Equivalent on January 25, 1979, 13 days after the submission was received.
What is the product code of K790083?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.