Percutaneous Introducer Set
FDA 510(k) K800462 · Medical Components, Inc.
510(k) numberK800462
Submission
- Device name
- Percutaneous Introducer Set
- Applicant
- Medical Components, Inc.
Mchenry, IL, US - Received
- February 29, 1980
- Decision date
- March 19, 1980
- 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 |
|---|---|---|
| K250836 | 14F Duo-Flow® Side X Side Double Lumen CatheterMPB · Traditional | 08/12/2025SE |
| K141633 | Pro-Picc with Valve TechnologyLJS · Traditional | 09/29/2014SE |
| K132880 | Medcomp Power Injectable Safety Huber NeedleFPA · Traditional | 01/08/2014SE |
| K131687 | 6F X 60CM Triple Pro-Line CT Basic Ir SetLJS · Traditional | 08/16/2013SE |
| K130687 | 2F & 3F Vascu-Sheath Tearaway IntroducerDYB · Traditional | 08/15/2013SE |
| K130923 | 5F Dignity CT Titanium PortLJT · Traditional | 07/31/2013SE |
| K124046 | Valved Tearaway Introducer Generation IIDYB · Traditional | 06/03/2013SE |
| K123617 | 3F Pro-PiccLJS · Traditional | 05/15/2013SE |
| K122423 | Vasu-PiccLJS · Traditional | 12/12/2012SE |
| K121848 | Split Cath III 24CM Split Cath III 24CM Split Cath III 32CM Cath III 36CM Split Cath III…MSD · Special | 09/21/2012SESK |
Questions and answers
When was Percutaneous Introducer Set cleared by the FDA?
Percutaneous Introducer Set (K800462) received a 510(k) decision of Substantially Equivalent on March 19, 1980, 19 days after the submission was received.
What is the product code of K800462?
The FDA product code is DRE – Dilator, Vessel, For Percutaneous Catheterization, a Class II (moderate risk) device regulated under 21 CFR 870.1310.