Connecting Set
FDA 510(k) K914128 · Procedure Products, Inc.
510(k) numberK914128
Submission
- Device name
- Connecting Set
- Applicant
- Procedure Products, Inc.
Vancouver, WA, US - Received
- September 13, 1991
- Decision date
- November 27, 1991
- 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 |
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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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| K161812 | Freedom SyringeFMF · Abbreviated | 03/27/2017SE |
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| K922536 | Torque DeviceDQX · Traditional | 12/10/1992SE |
| K910673 | Bag SpigotKPE · Traditional | 04/24/1991SE |
| K884985 | Modified 10CC Syringe Control Ring SetFMF · Traditional | 12/20/1988SE |
| K874747 | 10CC Syringe Control Ring SetFMF · Traditional | 02/04/1988SE |
| K874037 | Angio Waste Fluids Dump BagDQO · Traditional | 01/29/1988SE |
| K853749 | Custom Coronary Manifold KitsDTL · Traditional | 01/13/1986SE |
| K842173 | Disposable StopcocksFMG · Traditional | 09/05/1984SE |
| K833554 | Material Addition Lexan & K-ResinDQO · Traditional | 03/12/1984SE |
Questions and answers
When was Connecting Set cleared by the FDA?
Connecting Set (K914128) received a 510(k) decision of Substantially Equivalent on November 27, 1991, 75 days after the submission was received.
What is the product code of K914128?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.