Bigboss Catheters Mantatay Catheter Mantaray Guidewires
FDA 510(k) K120533 · Bridgepoint Medical
510(k) numberK120533
Submission
- Device name
- Bigboss Catheters Mantatay Catheter Mantaray Guidewires
- Applicant
- Bridgepoint Medical
Plymouth, MN, US - Received
- February 22, 2012
- Decision date
- May 22, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PDU – Catheter For Crossing Total Occlusions
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
To facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including subchronic and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention, such as angioplasty, atherectomy or stent placement.
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| K251376 | LimFlow ARCPDU · Special | LimFlow, Inc. | 05/31/2025SE |
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| K230159 | SoundBite® Crossing System XS PeripheralPDU · Traditional | Soundbite Medical Solutions, Inc. | 08/28/2023SE |
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| K221163 | Tunnel Crossing CatheterPDU · Traditional | Tractus Vascular, LLC | 01/19/2023SE |
| K221541 | LimFlow ARCPDU · Traditional | LimFlow, Inc. | 08/31/2022SE |
| K220544 | DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0)PDU · Traditional | Ra Medical Systems,Inc | 06/29/2022SE |
More from Ra Medical Systems,Inc
| 510(k) | Device | Decision |
|---|---|---|
| K122795 | Stingray GuidewiresDQX · Special | 11/08/2012SE |
| K121745 | Mantaray GuidewiresDQX · Special | 07/13/2012SE |
| K120881 | Mantaray GuidewiresDQX · Special | 04/18/2012SE |
| K120129 | Mantaray CatheterDQY · Special | 02/03/2012SE |
| K113589 | Bigboss CatheterDQY · Special | 01/04/2012SE |
| K111963 | Bridgepoint Medical Mantaray(Tm) CatheterDQY · Special | 08/10/2011SE |
| K111488 | Mantaray Guidewire Model M-6000, M-6001, M-6002, M-6003DQX · Special | 06/30/2011SE |
| K101591 | Stingray Orienting Balloon CatheterDQY · Special | 08/06/2010SE |
| K091841 | Bridgepoint Medical Crossboss Catheter, Model M-2000DQY · Special | 09/02/2009SE |
| K081130 | Bridgepoint Medical Crossboss Percutaneous Coronary CatheterDQY · Traditional | 05/14/2009SE |
Questions and answers
When was Bigboss Catheters Mantatay Catheter Mantaray Guidewires cleared by the FDA?
Bigboss Catheters Mantatay Catheter Mantaray Guidewires (K120533) received a 510(k) decision of Substantially Equivalent on May 22, 2012, 90 days after the submission was received.
What is the product code of K120533?
The FDA product code is PDU – Catheter For Crossing Total Occlusions, a Class II (moderate risk) device regulated under 21 CFR 870.1250.