510(k) K864533
- Device
- HOOD BIFURCATED T-TUBE
- Applicant
- HOOD LABORATORIES
- 510(k) number
- K864533
- Product code
- BTR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-03-09
- Date received
- 1986-11-18
- Regulation
- 868.5730
- Classification name
- Tube, Tracheal (w/wo Connector)
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- WILLIAM MCCALLUM,III
- Address
- 575 Washington St. Pembroke MA US 02359 02359
FDA Registration Numbers#
- 1718873
- 8021995
- 3011237770
- 3014479313
- 1928237
- 1220477
- 3013002100
- 3005382983
- 3010220595
- 3015443199
- 1000393132
- 3016844398
- 1047843
- 1820334
- 3011050534
- 1048735
- 3003935342
- 1930870
- 3021187119
- 1420054
- 3014544429
- 3007502289
- 3018094310
- 3002807561
- 3010594263
- 2024311
- 3020460367
- 1643817
- 2030598
- 3009888344
- 3011137372
- 3022518300
- 9617604
- 3000308637
- 2648727
- 3027579175
- 1824231
- 2183744
- 3016548968
- 3007713076
- 3014279513
- 3007289408
- 1721686
- 3030412764
- 3007728072
- 2936999
- 2431166
- 3004527595
- 3004569180
- 2028523
- 3009959868
- 3004111573
- 1061771
- 1045254
- 3017406698
- 3043543260
- 3013055499
- 3009050824
- 3005609751
- 9612501
- 3003898360
- 3009771213
- 3009526575
- 3012104670
- 3002808486
- 1018233
- 3004365956
- 3009973505
- 1221763
- 3004992992
- 3027977504
- 3005160810
- 8030673
- 1319639
- 3010042047
- 8020889
- 8040412
- 2031966
- 1219795
- 8041005
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code BTR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253437 | Spiro-VISTA | Spiro Robotics | 2026-06-12 |
| 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 |
Legacy Summary#
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FDA Review#
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