Deseret Guidewire Introducer III
FDA 510(k) K920408 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK920408
Submission
- Device name
- Deseret Guidewire Introducer III
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Sandy, UT, US - Received
- January 31, 1992
- Decision date
- April 7, 1992
- 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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| K233975 | Zoom 6F Insert CathetersDQO · Traditional | Imperative Care, Inc. | 04/02/2024SE |
| 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 Deseret Guidewire Introducer III cleared by the FDA?
Deseret Guidewire Introducer III (K920408) received a 510(k) decision of Substantially Equivalent on April 7, 1992, 67 days after the submission was received.
What is the product code of K920408?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.