Cbis Catheter Pull-Back Device
FDA 510(k) K921879 · Cardiovascular Imaging Systems, Inc.
510(k) numberK921879
Submission
- Device name
- Cbis Catheter Pull-Back Device
- Applicant
- Cardiovascular Imaging Systems, Inc.
Sunnyvale, CA, US - Received
- April 20, 1992
- Decision date
- July 16, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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| K254278 | Arterial Pressure Monitoring Set/TrayDQO · Special | Spectrum Vascular | 03/25/2026SE |
| K250751 | DualView CatheterDQO · Traditional | Terumo Corporation | 07/17/2025SE |
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| K242420 | pNOVUS 21 MicrocatheterDQO · Traditional | Phenox, Ltd. | 11/12/2024SE |
| K233268 | Impress Angiographic CatheterDQO · Special | Merit Medical Systems, Inc. | 05/22/2024SE |
| 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 |
More from Cordis US Corp
| 510(k) | Device | Decision |
|---|---|---|
| K970049 | BSC, Sonicath Ultra Imaging Catheter 3.2F/20MHZ(37410/456221 & BSC, Sonicath Ultra…ITX · Traditional | 06/20/1997SE |
| K942231 | Microview Ii/Microrail II CathetersDQO · Traditional | 08/01/1994SE |
| K933517 | Automatic Pull Back DeviceDQX · Traditional | 10/15/1993SE |
| K930232 | Cvis Insight Imaging Guide CatheterDQO · Traditional | 07/21/1993SE |
| K924922 | Cvis Insight Imaging CatheterDQO · Traditional | 06/29/1993SE |
| K930311 | Cvis LongviewDQO · Traditional | 06/02/1993SE |
| K921750 | Cvis Insight III SystemITX · Traditional | 07/13/1992SE |
| K921631 | Cvis Insight Imaging Catheter for IntraluminalITX · Traditional | 07/02/1992SE |
| K921148 | Cvis Insight Catheters for Intracardiac UseITX · Traditional | 06/16/1992SE |
| K921147 | Cvis Insight Imaging Catheter for Intraluminal UseITX · Traditional | 06/16/1992SE |
Questions and answers
When was Cbis Catheter Pull-Back Device cleared by the FDA?
Cbis Catheter Pull-Back Device (K921879) received a 510(k) decision of Substantially Equivalent on July 16, 1992, 87 days after the submission was received.
What is the product code of K921879?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.