Heart Catheterization Tray Set
FDA 510(k) K840022 · Medi-Plast Intl., Inc.
510(k) numberK840022
Submission
- Device name
- Heart Catheterization Tray Set
- Applicant
- Medi-Plast Intl., Inc.
Mchenry, IL, US - Received
- January 5, 1984
- Decision date
- February 4, 1984
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K954284 | Medi-Plast 2 Port Manifold (Right on)DTL · Traditional | 02/12/1996SE |
| K873588 | 10CC Control SyringeFMF · Traditional | 10/23/1987SE |
| K863402 | Medi-Plast Disposable ManifoldDTL · Traditional | 10/22/1986SE |
| K861785 | Fluoroscope Band BagJAA · Traditional | 06/13/1986SE |
| K851489 | Arterial-Venous Compression Dressing · Traditional | 06/11/1985SE |
| K842136 | Sterile Pan SetFRG · Traditional | 07/06/1984SE |
| K840021 | Operating Room Tray SetFSM · Traditional | 03/15/1984SE |
| K811268 | Bottle-To-BottleKPE · Traditional | 06/18/1981SE |
| K811234 | I.V. Bottle (Ridgid)KPE · Traditional | 06/18/1981SE |
| K811233 | I.V. Plastic BagKPE · Traditional | 06/17/1981SE |
Questions and answers
When was Heart Catheterization Tray Set cleared by the FDA?
Heart Catheterization Tray Set (K840022) received a 510(k) decision of Substantially Equivalent on February 4, 1984, 30 days after the submission was received.
What is the product code of K840022?
The FDA product code is DRE – Dilator, Vessel, For Percutaneous Catheterization, a Class II (moderate risk) device regulated under 21 CFR 870.1310.