Ultra High Pressure Injector Lines
FDA 510(k) K023591 · Deroyal Industries, Inc.
510(k) numberK023591
Submission
- Device name
- Ultra High Pressure Injector Lines
- Applicant
- Deroyal Industries, Inc.
Powell, TN, US - Received
- October 25, 2002
- Decision date
- June 18, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQO – Catheter, Intravascular, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1200
- Specialty
- Cardiovascular
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| K232536 | Soldier MicrocatheterDQO · Traditional | Embolx, Inc. | 02/23/2024SE |
| K232573 | INFINITI Ambi Angiographic CatheterDQO · Traditional | Cordis US Corp | 11/21/2023SE |
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Questions and answers
When was Ultra High Pressure Injector Lines cleared by the FDA?
Ultra High Pressure Injector Lines (K023591) received a 510(k) decision of Substantially Equivalent on June 18, 2003, 236 days after the submission was received.
What is the product code of K023591?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.