Balloon Wedge Pressure Catheter
FDA 510(k) K822034 · Ziehm International, Inc.
510(k) numberK822034
Submission
- Device name
- Balloon Wedge Pressure Catheter
- Applicant
- Ziehm International, Inc.
Annapolis, MD, US - Received
- July 12, 1982
- Decision date
- August 24, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DYG – Catheter, Flow Directed
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1240
- Specialty
- Cardiovascular
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| K233824 | Swan-Ganz catheterDYG · Traditional | Edwards Lifesciences, LLC | 06/06/2024SE |
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| K160084 | Swan Ganz CathetersDYG · Traditional | Edwards Lifesciences, LLC | 05/03/2016SE |
| K094048 | Percupro Messenger Balloon CatheterDYG · Traditional | Cardiosolutions, Inc. | 07/14/2011SE |
| K081052 | Occlusion Balloon Catheter, Model VenosDYG · Traditional | Oscor, Inc. | 06/18/2008SE |
| K010253 | Angio Flow Thermodilution Catheter, Model AF-CATH-01; Angioflow Meter, Models HQ100 and…DYG · Traditional | Transonic Systems, Inc. | 03/19/2002SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K011292 | Ziehm VisionOWB · Traditional | 06/20/2001SE |
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| K902196 | Modified Stick-Gard Safety NeedleFPA · Traditional | 06/26/1990SE |
| K894021 | Mobile X-Ray UnitIZL · Traditional | 09/01/1989SE |
| K894041 | Pump-Ject Syringe with Luer-LockFRN · Traditional | 08/28/1989SE |
| K890620 | Stick-Gard Safety NeedleFMI · Traditional | 02/28/1989SE |
| K882133 | Mammo MIZH · Traditional | 09/19/1988SE |
| K843311 | IV Admin. Set for MVP 1 Infusion PumpFRN · Traditional | 03/13/1985SE |
| K842263 | MTP E.V. Infusion PumpFRN · Traditional | 07/25/1984SE |
| K831407 | Cardiac Output ComputerDXG · Traditional | 10/14/1983SE |
Questions and answers
When was Balloon Wedge Pressure Catheter cleared by the FDA?
Balloon Wedge Pressure Catheter (K822034) received a 510(k) decision of Substantially Equivalent on August 24, 1982, 43 days after the submission was received.
What is the product code of K822034?
The FDA product code is DYG – Catheter, Flow Directed, a Class II (moderate risk) device regulated under 21 CFR 870.1240.