Sequitor Steerable Guidewire, Models SQR18XX and SQR14XX
FDA 510(k) K061171 · Biosphere Medical, Inc.
510(k) numberK061171
Submission
- Device name
- Sequitor Steerable Guidewire, Models SQR18XX and SQR14XX
- Applicant
- Biosphere Medical, Inc.
North Attleboro, MA, US - Received
- April 27, 2006
- Decision date
- June 2, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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
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| K251385 | InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire…DQX · Traditional | Merit Medical Ireland, Ltd. | 01/21/2026SE |
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| K113822 | Quadrasphere 30 to 60HCG · Special | 03/08/2012SE |
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| K062126 | Embocath Plus Infusion Microcatheter, Model ECP-100 and ECP-135DQO · Special | 08/09/2006SE |
| K021397 | Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid EmbolizationNAJ · Traditional | 11/22/2002SE |
| K010026 | Embogold MicrosphereHCG · Special | 06/21/2001SE |
| K003105 | Biosphere Medical Infusion CatheterDQO · Traditional | 05/22/2001SE |
| K991549 | Embosphere MicrospheresHCG · Traditional | 04/26/2000SE |
Questions and answers
When was Sequitor Steerable Guidewire, Models SQR18XX and SQR14XX cleared by the FDA?
Sequitor Steerable Guidewire, Models SQR18XX and SQR14XX (K061171) received a 510(k) decision of Substantially Equivalent on June 2, 2006, 36 days after the submission was received.
What is the product code of K061171?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.