Surefire Guide Sheath
FDA 510(k) K113737 · Surefire Medical, Inc.
510(k) numberK113737
Submission
- Device name
- Surefire Guide Sheath
- Applicant
- Surefire Medical, Inc.
Miami, FL, US - Received
- December 20, 2011
- Decision date
- February 23, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQO – Catheter, Intravascular, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1200
- Specialty
- Cardiovascular
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| K122506 | Surefire High Flow Angiographic Catheter, AccessDQX · Traditional | 09/17/2012SE |
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Questions and answers
When was Surefire Guide Sheath cleared by the FDA?
Surefire Guide Sheath (K113737) received a 510(k) decision of Substantially Equivalent on February 23, 2012, 65 days after the submission was received.
What is the product code of K113737?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.