Cordis Endovascular Temporary Occlusion Balloon Catheter
FDA 510(k) K984214 · Cordis Neurovascular, Inc.
510(k) numberK984214
Submission
- Device name
- Cordis Endovascular Temporary Occlusion Balloon Catheter
- Applicant
- Cordis Neurovascular, Inc.
Miami Lake, FL, US - Received
- November 24, 1998
- Decision date
- August 10, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DXC – Clamp, Vascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4450
- Specialty
- Cardiovascular
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More from Vascular Graft Solutions, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K082324 | Trufill DCS SyringeHCG · Special | 09/12/2008SE |
| K080967 | Trufill DCS Orbit Detachable Coil and Trufill DCS Syringe or Trufill DCS Syringe II…HCG · Special | 05/02/2008SE |
| K071962 | Vascular Occlusion System (Trufill Pushable Coils and Trupush Coil Pusher)HCG · Special | 09/26/2007SE |
| K070279 | Modification to Hypertransit Infusion CatheterKRA · Special | 03/14/2007SE |
| K063254 | The Trufill DCS Detachable Coil System; the Trufill DCS Orbit Detachable Coil SystemHCG · Traditional | 12/07/2006SE |
| K053197 | Trufill DCS Orbit Detachable Coil System Line ExtensionHCG · Special | 12/15/2005SE |
| K043538 | Hypertransit Infusion CatheterKRA · Traditional | 04/18/2005SE |
| K032553 | Trufill DCS Orbit Detachable Coil and Trufill DCS Syringe, Also Known AS Trufill DCS…HCG · Special | 09/23/2003SE |
| K030963 | Trufill DCS Orbit Detachable Coil and Trufill DCS Syringe, Also Known AS the Trufill DCS…HCG · Traditional | 06/20/2003SE |
| K021591 | Prowler Select (10, 14, and Plus) Infusion Catheters with and Without Pre-Shaped TipsKRA · Special | 05/22/2002SE |
Questions and answers
When was Cordis Endovascular Temporary Occlusion Balloon Catheter cleared by the FDA?
Cordis Endovascular Temporary Occlusion Balloon Catheter (K984214) received a 510(k) decision of Substantially Equivalent on August 10, 1999, 259 days after the submission was received.
What is the product code of K984214?
The FDA product code is DXC – Clamp, Vascular, a Class II (moderate risk) device regulated under 21 CFR 870.4450.