Hospira Cath Lab Convenience Kits
FDA 510(k) K052865 · Icu Medical, Inc.
510(k) numberK052865
Submission
- Device name
- Hospira Cath Lab Convenience Kits
- Applicant
- Icu Medical, Inc.
Lake Forest, IL, US - Received
- October 11, 2005
- Decision date
- December 22, 2005
- 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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| K233975 | Zoom 6F Insert CathetersDQO · Traditional | Imperative Care, Inc. | 04/02/2024SE |
| K232536 | Soldier MicrocatheterDQO · Traditional | Embolx, Inc. | 02/23/2024SE |
| K232573 | INFINITI Ambi Angiographic CatheterDQO · Traditional | Cordis US Corp | 11/21/2023SE |
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Questions and answers
When was Hospira Cath Lab Convenience Kits cleared by the FDA?
Hospira Cath Lab Convenience Kits (K052865) received a 510(k) decision of Substantially Equivalent on December 22, 2005, 72 days after the submission was received.
What is the product code of K052865?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.