Target Therapeutics Radiopaque Stylet
FDA 510(k) K914001 · Target Therapeutics
510(k) numberK914001
Submission
- Device name
- Target Therapeutics Radiopaque Stylet
- Applicant
- Target Therapeutics
San Jose, CA, US - Received
- September 6, 1991
- Decision date
- November 22, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DRB – Stylet, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1380
- Specialty
- Cardiovascular
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| K170298 | Liberator Beacon Tip Locking StyletDRB · Traditional | Cook Incorporated | 10/18/2017SE |
| K142116 | LLD EzDRB · Special | Spectranetics, Inc. | 08/12/2014SE |
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| K072864 | St. Jude Medical, CPS Duo Left Heart Lead Delivery SystemDRB · Traditional | St. Jude Medical, Cardiac Rhythm Management Divisi | 03/13/2008SE |
| K053019 | Acuity Steerable Stylet AccessoryDRB · Traditional | Guidant Corporation | 03/03/2006SE |
| K052965 | Easytrak 2 Stylet, Models 4826, 4829, 4832.DRB · Traditional | Guidant Corporation | 02/13/2006SE |
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| K964112 | Berenstein CoilKRD · Traditional | 02/26/1997SE |
| K963307 | GDC Patient Return Electtrode Model 45021HCG · Traditional | 12/17/1996SE |
| K962503 | Guglielmi Detachable CoilHCG · Traditional | 09/20/1996SE |
| K961923 | Berenstein CoilHCG · Traditional | 08/15/1996SE |
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Questions and answers
When was Target Therapeutics Radiopaque Stylet cleared by the FDA?
Target Therapeutics Radiopaque Stylet (K914001) received a 510(k) decision of Substantially Equivalent on November 22, 1991, 77 days after the submission was received.
What is the product code of K914001?
The FDA product code is DRB – Stylet, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1380.