Inner-Lock Introducer Sheath
FDA 510(k) K051468 · Rex Medical
510(k) numberK051468
Submission
- Device name
- Inner-Lock Introducer Sheath
- Applicant
- Rex Medical
Great Neck, NY, US - Received
- June 3, 2005
- Decision date
- August 4, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DYB – Introducer, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1340
- Specialty
- Cardiovascular
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| K081410 | Option Vena Cava FilterDTK · Traditional | 06/04/2009SE |
| K071422 | 15.5F Hemo-Stream Hemodialysis Catheter SetMSD · Traditional | 08/22/2007SESK |
| K040252 | Cleaner Rotational Thrombectomy System KitMCW · Special | 02/26/2004SE |
| K033793 | Cleaner II Rotational Thrombectomy SystemMCW · Traditional | 12/16/2003SE |
| K032569 | Short Introducer SheathDYB · Special | 09/16/2003SE |
| K031610 | Rex Medical Cleaner Rotational Thrombectomy SystemMCW · Traditional | 05/27/2003SE |
Questions and answers
When was Inner-Lock Introducer Sheath cleared by the FDA?
Inner-Lock Introducer Sheath (K051468) received a 510(k) decision of Substantially Equivalent on August 4, 2005, 62 days after the submission was received.
What is the product code of K051468?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.