Foursnare Vascular Retrieval Snare
FDA 510(k) K112185 · Cook, Inc.
510(k) numberK112185
Submission
- Device name
- Foursnare Vascular Retrieval Snare
- Applicant
- Cook, Inc.
Bloomington, IN, US - Received
- July 29, 2011
- Decision date
- November 2, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MMX – Device, Percutaneous Retrieval
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5150
- Specialty
- Cardiovascular
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| K190903 | Lawson Retrograde Nephrostomy Wire Puncture SetLJE · Traditional | 12/16/2019SE |
| K193133 | Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi…JOH · Special | 12/12/2019SE |
| K191163 | Lumax Guiding CatheterDQY · Traditional | 12/12/2019SE |
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Questions and answers
When was Foursnare Vascular Retrieval Snare cleared by the FDA?
Foursnare Vascular Retrieval Snare (K112185) received a 510(k) decision of Substantially Equivalent on November 2, 2011, 96 days after the submission was received.
What is the product code of K112185?
The FDA product code is MMX – Device, Percutaneous Retrieval, a Class II (moderate risk) device regulated under 21 CFR 870.5150.