Teleflex Steerable Guidewire
FDA 510(k) K871850 · Teleflexmedical, Inc.
510(k) numberK871850
Submission
- Device name
- Teleflex Steerable Guidewire
- Applicant
- Teleflexmedical, Inc.
Jeffrey, NH, US - Received
- May 12, 1987
- Decision date
- January 27, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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Questions and answers
When was Teleflex Steerable Guidewire cleared by the FDA?
Teleflex Steerable Guidewire (K871850) received a 510(k) decision of Substantially Equivalent on January 27, 1988, 260 days after the submission was received.
What is the product code of K871850?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.