Modification to Atlantis PV Imaging Catheter, Model 36456
FDA 510(k) K041727 · Boston Scientific Scimed, Inc.
510(k) numberK041727
Submission
- Device name
- Modification to Atlantis PV Imaging Catheter, Model 36456
- Applicant
- Boston Scientific Scimed, Inc.
Fremont, CA, US - Received
- June 25, 2004
- Decision date
- July 23, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- OBJ – Catheter, Ultrasound, Intravascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1200
- Specialty
- Cardiovascular
For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.
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| K260816 | OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter…OBJ · Special | Boston Scientific | 04/08/2026SE |
| K253399 | Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS CatheterOBJ · Special | Volcano Corporation (Dba Philips Image Guided… | 10/28/2025SE |
| K250955 | XC11 ICE System, USAOBJ · Traditional | Yorlabs, Inc. | 10/22/2025SE |
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| K251211 | ViewFlex Xtra ICE Catheter; ViewFlex Eco Reprocessed ICE Catheter; Advisor HD Grid…OBJ · Special | Abbott Medical | 05/23/2025SE |
| K251231 | ViewFlex X ICE Catheter, Sensor EnabledOBJ · Special | Abbott Medical | 05/20/2025SE |
| K251103 | VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac…OBJ · Special | Philips Image Guided Therapy Corporation | 05/09/2025SE |
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| K030617 | PT2 Guide Wire and Addwire Extension WireDQX · Abbreviated | 05/21/2003SE |
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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 |
| K000956 | Modification to Scimed 6F Impulse Angiographic CathatersDQO · Special | 04/21/2000SE |
| K993232 | Wallstent Biliary Endoprosthesis and Unistep Plus Delivery SystemFGE · Traditional | 12/30/1999SESU |
Questions and answers
When was Modification to Atlantis PV Imaging Catheter, Model 36456 cleared by the FDA?
Modification to Atlantis PV Imaging Catheter, Model 36456 (K041727) received a 510(k) decision of Substantially Equivalent on July 23, 2004, 28 days after the submission was received.
What is the product code of K041727?
The FDA product code is OBJ – Catheter, Ultrasound, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 870.1200.