510(k) K141747
- Device
- RHINOGUARD
- Applicant
- DAVIS MEDICAL
- 510(k) number
- K141747
- Product code
- BTR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-04-20
- Date received
- 2014-06-30
- Regulation
- 868.5730
- Classification name
- Tube, Tracheal (w/wo Connector)
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MICHELLE LOTT
- Address
- 12602 N Summer Wind Dr. Marana AZ US 85658 85658
FDA Registration Numbers#
- 3030078769
- 3012050423
- 2024311
- 1061771
- 3003898360
- 3011987967
- 3003674698
- 1526611
- 3014656749
- 3016844398
- 3007289408
- 3007728072
- 3010400865
- 2431166
- 3002807314
- 3010934635
- 3011237770
- 1824231
- 1052728
- 1220850
- 3015997711
- 1420054
- 9617604
- 3007502289
- 3021187119
- 3010202439
- 2032112
- 1047843
- 3018094310
- 3002808486
- 3015895045
- 3009973505
- 8030673
- 3005803389
- 3014544429
- 1048735
- 1319639
- 1018233
- 3007713076
- 1928237
- 8021995
- 2031966
- 3007740622
- 1721686
- 3013188547
- 3014479313
- 3000308637
- 1220477
- 3010220595
- 3015443199
- 3005580113
- 8020889
- 3010594263
- 1219795
- 3003903031
- 3009307931
- 3004111573
- 3005160810
- 1825146
- 3003935342
- 3008806809
- 1643817
- 2020550
- 3013055499
- 1820334
- 3009771213
- 3016438694
- 1045254
- 2936999
- 1526534
- 3027579175
- 3043226252
- 3004365956
- 9681384
- 3002807561
- 3009888344
- 3007682555
- 3030733800
- 1718873
Source Documents#
Other 510(k) Records For Product Code BTR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250173 | Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley™ Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley™ Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley™ Oral RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (115-XXOR) Shiley™ Nasal RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (119-XXNR) | Covidien, LLC | 2025-10-06 |
| K243785 | Shiley™ Oral/Nasal Tracheal Tube with TaperGuard™ Cuff Reinforced, Murphy Eye Shiley™ Tracheal Tube TaperGuard™ Cuff Reinforced with Stylet Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley™ Oral/Nasal Tracheal Tube Cuffless Reinforced | Covidien, LLC | 2025-09-25 |
| K243579 | AeroJet Ventilation Catheter | Pipeline Medical Products, LLC | 2025-08-13 |
| K251499 | Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova Intubating Introducer (C-CAE-14.0-70-FIC); Frova Intubating Introducer (C-CAE-14.0-70-FIC-SPOPS) | William Cook Europe Aps | 2025-06-11 |
| K250243 | ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.0) (038-995-070U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.5) (038-995-075U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 8.0) (038-995-080U) | Flexicare Medical Limited. | 2025-05-20 |
| K242495 | LMA Fastrach ETT SU | Teleflex Medical | 2025-04-29 |
| K241451 | Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch Endotracheal Tubes (Safety Clear Pediatric) | Teleflex Incorporated | 2025-02-11 |
| K233341 | Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410) | Covidien, LLC | 2024-05-20 |
| K223130 | Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160) | Covidien | 2023-08-30 |
| K211543 | Wei Nasal Jet Tube | Well Lead Medical Co., Ltd. | 2022-07-21 |
| K213028 | Tenax Laser Resistant Endotracheal Tube | Bryan Medical, Inc. | 2021-10-21 |
| K200761 | Tenax Laser Resistant Endotracheal Tube | Bryan Medical, Inc. | 2020-11-25 |
| K192120 | Venner PneuX™ ETT (Endotracheal Tube) 6 mm, Venner PneuX™ ETT (Endotracheal Tube) 7 mm, Venner PneuX™ ETT (Endotracheal Tube) 8 mm, Venner PneuX™ ETT (Endotracheal Tube) 9 mm | Venner Medical (Singapore) Pte, Ltd. | 2020-02-14 |
| K190878 | Trach- Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff, Trach- Vac Endotracheal Tube (SFTVVC) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff | Salter Labs, Inc. | 2020-01-10 |
| K182739 | Endotracheal Tube with Evacuation Lumen | Well Lead Medical Co., Ltd. | 2019-12-11 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases