Scimed Impulse Angiographic Catheters
FDA 510(k) K992123 · Boston Scientific Scimed, Inc.
510(k) numberK992123
Submission
- Device name
- Scimed Impulse Angiographic Catheters
- Applicant
- Boston Scientific Scimed, Inc.
Maple Grove, MN, US - Received
- June 23, 1999
- Decision date
- August 23, 1999
- 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
Other 510(k)s with product code DQO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261455 | Arterial Pressure Monitoring Set/TrayDQO · Traditional | Spectrum Vascular | 06/26/2026SE |
| K252702 | Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF…DQO · Traditional | Bioptimal International Pte. , Ltd. | 05/28/2026SE |
| K254278 | Arterial Pressure Monitoring Set/TrayDQO · Special | Spectrum Vascular | 03/25/2026SE |
| K250751 | DualView CatheterDQO · Traditional | Terumo Corporation | 07/17/2025SE |
| K242966 | Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterDQO · Traditional | Gentuity, LLC | 01/31/2025SE |
| 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 |
|---|---|---|
| K041727 | Modification to Atlantis PV Imaging Catheter, Model 36456OBJ · Special | 07/23/2004SE |
| K030617 | PT2 Guide Wire and Addwire Extension WireDQX · Abbreviated | 05/21/2003SE |
| K024048 | Modification to Boston Scientific Express Biliary LD Premounted Stent SystemFGE · Special | 01/06/2003SESU |
| K021735 | Boston Scientific Ultra-Soft SV Balloon Dilatation CatheterDQY · Traditional | 08/08/2002SE |
| K021901 | Wallgraft Tracheobronchial Endoprothesis with Unistep Plus Delivery SystemJCT · Special | 07/09/2002SE |
| K012822 | Modificiation to: Biliary Wallstent Endoprostheis with Monorail Delivery System, Model…FGE · Special | 10/24/2001SESU |
| K012216 | Niroyal Biliary Premounted Stent SystemFGE · Special | 08/17/2001SESU |
| K000743 | Boston Scientific Scimed Atlantis Coronary Imaging Catheter, Model C4020DQO · Traditional | 09/06/2000SE |
| K000001 | Wallgraft Tracheobronchial Endoprosthesis and Unistep Delivery SystemJCT · Traditional | 06/05/2000SE |
| K000956 | Modification to Scimed 6F Impulse Angiographic CathatersDQO · Special | 04/21/2000SE |
Questions and answers
When was Scimed Impulse Angiographic Catheters cleared by the FDA?
Scimed Impulse Angiographic Catheters (K992123) received a 510(k) decision of Substantially Equivalent on August 23, 1999, 61 days after the submission was received.
What is the product code of K992123?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.