Catheter, Balloon Type
FDA 510(k) K950398 · Interventional Therapeutics Corp.
510(k) numberK950398
Submission
- Device name
- Catheter, Balloon Type
- Applicant
- Interventional Therapeutics Corp.
Fremont, CA, US - Received
- February 1, 1995
- Decision date
- October 5, 1995
- 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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| 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 |
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| 510(k) | Device | Decision |
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| K960832 | Occlusion Balloon CatheterMJN · Traditional | 05/29/1996SE |
| K945588 | Disposable 1CC Syringe with Luer LockFMF · Traditional | 02/10/1995SE |
| K944354 | Contour EmboliHCG · Traditional | 12/13/1994SE |
| K930456 | Intherm Single-Stick Radially Expanding DilatorKNT · Traditional | 11/17/1993SE |
| K914866 | Itc Contour Emboli, ModificationHCG · Traditional | 11/09/1993SE |
| K931025 | Intherm Stasis Valve SystemFGE · Traditional | 09/28/1993SE |
| K931278 | Intherm Single-Stick Radially Expanding DilatorGCJ · Traditional | 07/23/1993SE |
| K922609 | Itc Catheters W/ HydromerDQY · Traditional | 04/30/1993SE |
| K925876 | Itc Bunji Platinum Embolization CoilHCG · Traditional | 04/15/1993SE |
| K925523 | Itc Bunji Platinum Embolization CoilHCG · Traditional | 03/23/1993SE |
Questions and answers
When was Catheter, Balloon Type cleared by the FDA?
Catheter, Balloon Type (K950398) received a 510(k) decision of Substantially Equivalent on October 5, 1995, 246 days after the submission was received.
What is the product code of K950398?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.