Sheath Dilator Set
FDA 510(k) K802327 · Stanco Medical, Inc.
510(k) numberK802327
Submission
- Device name
- Sheath Dilator Set
- Applicant
- Stanco Medical, Inc.
Mchenry, IL, US - Received
- September 23, 1980
- Decision date
- October 10, 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 |
|---|---|---|
| K810643 | Universal Pacing Electrode KitLDF · Traditional | 04/08/1981SE |
| K810642 | Atrial-Ventricular Pacing Electrode KitLDF · Traditional | 04/08/1981SE |
| K802289 | Pericardiocentesis KitDOR · Traditional | 11/26/1980SE |
| K802288 | Swan Ganz Catheter Placement KitDYG · Traditional | 11/20/1980SE |
| K802287 | Right Atrial Line KitDQY · Traditional | 11/20/1980SE |
| K802259 | Transvenous Pacemaker Electrode KitLDF · Traditional | 10/23/1980SE |
| K802290 | Regional Intravenous Anesthesia KitCAZ · Traditional | 10/17/1980SE |
| K802328 | Disp. Tougy-Borst Type Adaptor W/PortDTZ · Traditional | 10/10/1980SE |
| K802326 | Pressure Monitoring LinesDRI · Traditional | 10/10/1980SE |
| K802260 | Vascular Catheter WireguidesDQX · Traditional | 10/10/1980SE |
Questions and answers
When was Sheath Dilator Set cleared by the FDA?
Sheath Dilator Set (K802327) received a 510(k) decision of Substantially Equivalent on October 10, 1980, 17 days after the submission was received.
What is the product code of K802327?
The FDA product code is DRE – Dilator, Vessel, For Percutaneous Catheterization, a Class II (moderate risk) device regulated under 21 CFR 870.1310.