Redifurl and Teperseal DL Intra-Aortic Balloon Catheters with Hydromer Coating
FDA 510(k) K935184 · St. Jude Medical, Inc.
510(k) numberK935184
Submission
- Device name
- Redifurl and Teperseal DL Intra-Aortic Balloon Catheters with Hydromer Coating
- Applicant
- St. Jude Medical, Inc.
Chelmsford, MA, US - Received
- October 26, 1993
- Decision date
- February 10, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DSP – System, Balloon, Intra-Aortic And Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3535
- Specialty
- Cardiovascular
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| K160218 | AutoMark ModuleDQK · Traditional | 12/13/2016SE |
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Questions and answers
When was Redifurl and Teperseal DL Intra-Aortic Balloon Catheters with Hydromer Coating cleared by the FDA?
Redifurl and Teperseal DL Intra-Aortic Balloon Catheters with Hydromer Coating (K935184) received a 510(k) decision of Substantially Equivalent on February 10, 1995, 472 days after the submission was received.
What is the product code of K935184?
The FDA product code is DSP – System, Balloon, Intra-Aortic And Control, a Class II (moderate risk) device regulated under 21 CFR 870.3535.