Product code DRB— Cardiovascular
ACUITY STEERABLE STYLET ACCESSORY
- Classification name
- Stylet, Catheter
- Device class
- Class 2
- Regulation
- 21 CFR 870.1380
- Advisory panel
- Cardiovascular
- Total cleared
- 28
- First cleared
- Most recent
Market context for product code DRB
FDA has cleared devices under product code DRB between 1977 and 2022, filed by 22 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2022
- 2019
- 2017
- 2014
- 2009
- 2008
- 2006
- 2005
- 2004
- 2001
- 2000
- 1999
- 1991
- 1988
- 1980
Top applicants under product code DRB
Adverse events under product code DRB
product code DRB- Death
- 36
- Injury
- 562
- Total
- 598
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code DRB
- K220280 — Arrow Stiffening Stylet
- K191469 — Biotronik Stylets
- K182660 — GaltTWS
- K170298 — Liberator Beacon Tip Locking Stylet
- K142116 — LLD EZ
- K090163 — STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078
- K080924 — MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151
- K072864 — ST. JUDE MEDICAL, CPS DUO LEFT HEART LEAD DELIVERY SYSTEM
- K053019 — ACUITY STEERABLE STYLET ACCESSORY
- K052965 — EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832.
- K043401 — SPECTRANETICS LLD CS, MODEL 518-039
- K040001 — STEERABLE STYLET
- K010906 — MEDTRONIC STYLET KIT, MODELS 6282, 6293, AND 6254
- K003535 — STYLET KIT, MODELS 6254,6282,6293
- K002534 — EUPALAMUS DEFLECTABLE STYLET, MODEL 01545
- K000955 — PLACER MODEL 6232 STEERABLE STYLET
- K000366 — FIXATION STYLETS, MODELS 335-287 AND 335-288
- K992664 — TFX MEDICAL STYLET CATHETER
- K993376 — ENSTYLET MODELS EC0010, EC0020
- K992863 — LEAD STYLET,MODELS 6505,6506,6507,6508
- K990713 — SPECTRANETICS LEAD LOCKING DEVICE (LLD) #1, #2, #3 LISTER
- K914001 — TARGET THERAPEUTICS RADIOPAQUE STYLET
- K913543 — THORACIC CATHETER STYLET
- K901281 — THERMO KOR-CONTINUOUS PULMONARY ARTERY THERMOMETER
- K905674 — LEAD STYLET
- K882097 — TUNNELING STYLET
- K802076 — STIFF STYLETS
- K770404 — OBTURATOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.