Cardiac Catheterization Pack
FDA 510(k) K850337 · Marwood Medical, Inc.
510(k) numberK850337
Submission
- Device name
- Cardiac Catheterization Pack
- Applicant
- Marwood Medical, Inc.
Greensboro, NC, US - Received
- January 28, 1985
- Decision date
- February 25, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DRE – Dilator, Vessel, For Percutaneous Catheterization
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1310
- Specialty
- Cardiovascular
Other 510(k)s with product code DRE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261310 | FlexTract Deflectable-Rotational Dilator Sheath SetDRE · Traditional | Merit Medical Systems, Inc. | 07/27/2026SE |
| K253616 | ProtekDilate Vascular Access KitDRE · Special | Sorin Group Italia S.R.L. | 12/19/2025SE |
| K251325 | VersaCross Connect Transseptal DilatorDRE · Special | Baylis Medical Company, Inc. | 05/29/2025SE |
| K242229 | Micro Ace Gold Advanced Micro Access SystemDRE · Traditional | Merit Medical Systems, Inc. | 01/15/2025SE |
| K241720 | VersaCross Connect Transseptal DilatorDRE · Special | Baylis Medical Company, Inc. | 07/12/2024SE |
| K233647 | VersaCross Connect Transseptal DilatorDRE · Special | Baylis Medical Company, Inc. | 12/14/2023SE |
| K232609 | Micro Ace Advanced Micro Access SystemDRE · Special | Merit Medical Systems, Inc. | 09/27/2023SE |
| K223472 | TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian…DRE · Special | Spectranetics, Inc. | 12/15/2022SE |
| K212784 | TightRail Guardian Motorized Dilator SheathDRE · Traditional | Spectranetics, Inc. | 08/24/2022SE |
| K211679 | Xtractor deviceDRE · Traditional | Xcardia Innovation , Ltd. | 02/17/2022SE |
More from Xcardia Innovation , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K850340 | Eye Procedure PackHOZ · Traditional | 05/22/1985SE |
| K850338 | Emergency Room Pack · Traditional | 03/25/1985SE |
| K850339 | Special Procedures PackFPA · Traditional | 03/12/1985SE |
| K850341 | Cardiovascular Set UpDQO · Traditional | 02/25/1985SE |
| K840620 | Tpn/Cvp Dressing Change KitFMC · Traditional | 05/30/1984SE |
| K840619 | I.V. Start KitFPA · Traditional | 03/27/1984SE |
Questions and answers
When was Cardiac Catheterization Pack cleared by the FDA?
Cardiac Catheterization Pack (K850337) received a 510(k) decision of Substantially Equivalent on February 25, 1985, 28 days after the submission was received.
What is the product code of K850337?
The FDA product code is DRE – Dilator, Vessel, For Percutaneous Catheterization, a Class II (moderate risk) device regulated under 21 CFR 870.1310.