Modification to Short Introducer Sheath
FDA 510(k) K042399 · Rex Medical, L.P.
510(k) numberK042399
Submission
- Device name
- Modification to Short Introducer Sheath
- Applicant
- Rex Medical, L.P.
Great Neck, NY, US - Received
- September 3, 2004
- Decision date
- December 17, 2004
- 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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Questions and answers
When was Modification to Short Introducer Sheath cleared by the FDA?
Modification to Short Introducer Sheath (K042399) received a 510(k) decision of Substantially Equivalent on December 17, 2004, 105 days after the submission was received.
What is the product code of K042399?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.