Laguna Softip Diagnostic Catheters
FDA 510(k) K961499 · Boston Scientific Scimed, Inc.
510(k) numberK961499
Submission
- Device name
- Laguna Softip Diagnostic Catheters
- Applicant
- Boston Scientific Scimed, Inc.
Plymouth, MN, US - Received
- April 18, 1996
- Decision date
- October 17, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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| K041727 | Modification to Atlantis PV Imaging Catheter, Model 36456OBJ · Special | 07/23/2004SE |
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| K021901 | Wallgraft Tracheobronchial Endoprothesis with Unistep Plus Delivery SystemJCT · Special | 07/09/2002SE |
| K012822 | Modificiation to: Biliary Wallstent Endoprostheis with Monorail Delivery System, Model…FGE · Special | 10/24/2001SESU |
| K012216 | Niroyal Biliary Premounted Stent SystemFGE · Special | 08/17/2001SESU |
| K000743 | Boston Scientific Scimed Atlantis Coronary Imaging Catheter, Model C4020DQO · Traditional | 09/06/2000SE |
| K000001 | Wallgraft Tracheobronchial Endoprosthesis and Unistep Delivery SystemJCT · Traditional | 06/05/2000SE |
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Questions and answers
When was Laguna Softip Diagnostic Catheters cleared by the FDA?
Laguna Softip Diagnostic Catheters (K961499) received a 510(k) decision of Substantially Equivalent on October 17, 1996, 182 days after the submission was received.
What is the product code of K961499?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.