Mantaray Guidewires
FDA 510(k) K120881 · Bridgepoint Medical
510(k) numberK120881
Submission
- Device name
- Mantaray Guidewires
- Applicant
- Bridgepoint Medical
Plymouth, MN, US - Received
- March 23, 2012
- Decision date
- April 18, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQX – Wire, Guide, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1330
- Specialty
- Cardiovascular
Other 510(k)s with product code DQX
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|---|---|---|---|
| K261281 | CROSSLEAD Standard 035 and CROSSLEAD Stiff 035DQX · Traditional | Filmecc Co., Ltd. | 09/03/2026SE |
| K253667 | Accoat Guide WireDQX · Traditional | Sp Medical A/S | 07/14/2026SE |
| K261640 | Merit MAK Nitinol/Gold-Tungsten Guide WireDQX · Special | Merit Medical Ireland , Ltd. | 07/13/2026SE |
| K254137 | InQwire Amplatz Guide WireDQX · Traditional | Merit Medical Ireland, Ltd. | 05/22/2026SE |
| K260544 | FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD…DQX · Special | FMD Co., Ltd. | 03/20/2026SE |
| K253746 | Enroute 0.014'' Transcarotid GuidewireDQX · Special | Lake Region Medical | 03/19/2026SE |
| K253262 | EmeryGlide (EG18008901)DQX · Special | Nano4imaging GmbH | 03/06/2026SE |
| K253847 | Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)DQX · Special | Merit Medical Ireland, Ltd. | 01/31/2026SE |
| K251385 | InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire…DQX · Traditional | Merit Medical Ireland, Ltd. | 01/21/2026SE |
| K252674 | Solo Pace Fusion System (SOLOFUSE1)DQX · Traditional | Solo Pace, Inc. | 01/09/2026SE |
More from Solo Pace, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K122795 | Stingray GuidewiresDQX · Special | 11/08/2012SE |
| K121745 | Mantaray GuidewiresDQX · Special | 07/13/2012SE |
| K120533 | Bigboss Catheters Mantatay Catheter Mantaray GuidewiresPDU · Traditional | 05/22/2012SE |
| 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 Mantaray Guidewires cleared by the FDA?
Mantaray Guidewires (K120881) received a 510(k) decision of Substantially Equivalent on April 18, 2012, 26 days after the submission was received.
What is the product code of K120881?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.