Stylet, Catheter
The Catheter Stylet is a semi-rigid cardiovascular accessory inserted into a catheter lumen to stiffen it and facilitate proper placement and navigation through vascular structures during catheterization procedures. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DRB and it is regulated under 21 CFR 870.1380 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- DRB
- Device Class
- FDA class 2
- Regulation Number
- 870.1380
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 28 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K220280 | Arrow Stiffening Stylet | Aug 30, 2022 | Substantially Equivalent | Arrow International, LLC (A subsidiary of Teleflex, Inc.) |
| K191469 | Biotronik Stylets | Aug 01, 2019 | Substantially Equivalent | Biotronik, Inc. |
| K182660 | GaltTWS | May 30, 2019 | Substantially Equivalent | Galt Medical Corp. |
| K170298 | Liberator Beacon Tip Locking Stylet | Oct 18, 2017 | Substantially Equivalent | Cook Incorporated |
| K142116 | LLD EZ | Aug 12, 2014 | Substantially Equivalent | Spectranetics, Inc. |
| K090163 | STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078 | Apr 01, 2009 | Substantially Equivalent | St Jude Medical |
| K080924 | MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151 | Apr 30, 2008 | Substantially Equivalent | St. Jude Medical, Cardiac Rhythm Management Divisi |
| K072864 | ST. JUDE MEDICAL, CPS DUO LEFT HEART LEAD DELIVERY SYSTEM | Mar 13, 2008 | Substantially Equivalent | St. Jude Medical, Cardiac Rhythm Management Divisi |
| K053019 | ACUITY STEERABLE STYLET ACCESSORY | Mar 03, 2006 | Substantially Equivalent | Guidant Corporation |
| K052965 | EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832. | Feb 13, 2006 | Substantially Equivalent | Guidant Corporation |
| K043401 | SPECTRANETICS LLD CS, MODEL 518-039 | Mar 16, 2005 | Substantially Equivalent | Spectranetics Corp. |
| K040001 | STEERABLE STYLET | Mar 09, 2004 | Substantially Equivalent | Synovis Surgical Innovations |
| K010906 | MEDTRONIC STYLET KIT, MODELS 6282, 6293, AND 6254 | Apr 05, 2001 | Substantially Equivalent | Medtronic Vascular |
| K003535 | STYLET KIT, MODELS 6254,6282,6293 | Feb 08, 2001 | Substantially Equivalent | Medtronic Vascular |
| K002534 | EUPALAMUS DEFLECTABLE STYLET, MODEL 01545 | Oct 18, 2000 | Substantially Equivalent | Eupalamus, LLC |
| K000955 | PLACER MODEL 6232 STEERABLE STYLET | Jun 16, 2000 | Substantially Equivalent | Medtronic Vascular |
| K000366 | FIXATION STYLETS, MODELS 335-287 AND 335-288 | Apr 14, 2000 | Substantially Equivalent | Accufix Research Institute |
| K992664 | TFX MEDICAL STYLET CATHETER | Apr 13, 2000 | Substantially Equivalent | Tfx Medical Group |
| K993376 | ENSTYLET MODELS EC0010, EC0020 | Jan 05, 2000 | Substantially Equivalent | Endocardial Solutions, Inc. |
| K992863 | LEAD STYLET,MODELS 6505,6506,6507,6508 | Nov 12, 1999 | Substantially Equivalent | Guidant Corp. |
| K990713 | SPECTRANETICS LEAD LOCKING DEVICE (LLD) #1, #2, #3 LISTER | Oct 22, 1999 | Substantially Equivalent | Spectranetics Corp. |
| K914001 | TARGET THERAPEUTICS RADIOPAQUE STYLET | Nov 22, 1991 | Substantially Equivalent | Target Therapeutics |
| K913543 | THORACIC CATHETER STYLET | Oct 04, 1991 | Substantially Equivalent | Intl. Medical Devices , Ltd. |
| K901281 | THERMO KOR-CONTINUOUS PULMONARY ARTERY THERMOMETER | Aug 28, 1991 | Substantially Equivalent | Val-Mark Medical, Inc. |
| K905674 | LEAD STYLET | Jan 30, 1991 | Substantially Equivalent | Cardiac Pacemakers, Inc. |
| K882097 | TUNNELING STYLET | Jul 28, 1988 | Substantially Equivalent | Quinton, Inc. |
| K802076 | STIFF STYLETS | Sep 26, 1980 | Substantially Equivalent | Cardiac Pacemakers, Inc. |
| K770404 | OBTURATOR | Mar 16, 1977 | Substantially Equivalent | Abbott Laboratories |
FEI Numbers
This FDA classification entry is associated with 35 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 35 registration numbers. Click on an entry to view related FDA registrations.