Adelante Breezeway
Adelante Breezeway is a delivery sheath for intracardiac placement of diagnostic or therapeutic devices, including access to the left atrium through a transseptal puncture. Its braided…
Adelante Breezeway is a delivery sheath for intracardiac placement of diagnostic or therapeutic devices, including access to the left atrium through a transseptal puncture. Its braided sheath includes a hemostatic valve and side port with a three-way stopcock.
The 10 Fr sheath comes in overall lengths of 63 or 81 cm. A dilator locks to the sheath hub, and distal side holes support flushing.
Listed Item
Delivery Sheath, 10F
Dilator Options
Dilator lengths are 68 or 86 cm, with profile curves of 55, 70, 90 or 120 degrees. These options support selection for the intended intracardiac access route. The sheath and dilator form the delivery assembly, and no separate accessories are supplied.
13manufacturers in China registered for this device type
55catalogue numbers in this listing
14510(k) clearances naming this product code
37recalls on this code
Who Else Makes It
Concentrated in Jiangsu (5), Beijing (3), Shanghai (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Mehow Innovative (Huizhou) Ltd. | Huizhou | Guangdong | Contract manufacturer | 11 |
| Tianjin Demax Medical Technology Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 5 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Shanghai INT Medical Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Lepu Medical Technology (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
| Beijing Target Medical Technologies Inc. | Beijing | Beijing | Contract manufacturer | 7 |
| Beijing Demax Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 5 |
| Curatia Medical Limited | Suzhou | Jiangsu | Specification developer | 5 |
| Tianjin Ethylene Oxide Sterilization Technology Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 4 |
| Shanghai Microport EP Medtech Co., Ltd. | Shanghai | Shanghai | Manufacturer | 3 |
| Becton Dickinson Medical Devices Co., Ltd. Suzhou | Suzhou | Jiangsu | Contract manufacturer | 2 |
| Cardiocycle Medical(Suzhou) Co., Ltd. | Suzhou | Jiangsu | Complaint-file establishment | 1 |
Showing 12 of 13. All 13 manufacturers in China registered for Introducer, Catheter
Record
| Listed by | Oscor Inc., United States |
|---|---|
| FDA product code | DYB |
| Device type | Introducer, Catheter |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1340 |
| Establishment | Contract manufacturer, Contract steriliser, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K101497 |
| Record published | 2017-10-03 |
| Record revised | 2026-02-04 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 5 to 30 °C |
| Sizes | Lumen/inner diameter 2.2 to 3.5 mm; angle 55 to 120 ° |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AB081045GW | Lumen/Inner Diameter 2.9 mm | In distribution |
| AB101072 | Sheath Length 61 cm | In distribution |
| AB063001 | Sheath Length 55 cm | In distribution |
| AB101074 | Sheath Length 61 cm | In distribution |
| AB1061FT | Dilator Length 66 cm | In distribution |
| AB081041GW | Dilator Length 66 cm | In distribution |
| AB083001 | Dilator Length 50 cm | In distribution |
| AB081044GW | Angle 55 ° | In distribution |
| AB063009 | Sheath Tip Curve TD | In distribution |
| AB083006 | Dilator Length 50 cm | In distribution |
| AB101078 | Lumen/Inner Diameter 3.5 mm | In distribution |
| AB081210 | Lumen/Inner Diameter 2.9 mm | In distribution |
| AB083000 | Sheath Length 45 cm | In distribution |
| AB101218 | Lumen/Inner Diameter 3.5 mm | In distribution |
| AB081045 | Lumen/Inner Diameter 2.9 mm | In distribution |
| AB101075 | Lumen/Inner Diameter 3.5 mm | In distribution |
| AB1004045 | Sheath Length 40 cm | In distribution |
| AB081043 | Dilator Length 66 cm | In distribution |
| AB081043GW | Dilator Length 66 cm | In distribution |
| AB073000 | Sheath Tip Curve RDC | In distribution |
| AB073009 | Sheath Tip Curve TD | In distribution |
| AB081046 | Sheath Length 79 cm | In distribution |
| AB073004 | Dilator Length 60 cm | In distribution |
| AB081044 | Dilator Length 84 cm | In distribution |
| AB081040 | Angle 55 ° | In distribution |
| AB081041 | Lumen/Inner Diameter 2.9 mm | In distribution |
| AB101219 | Dilator Length 84 cm | In distribution |
| AB081042GW | Angle 90 ° | In distribution |
| AB063003 | Sheath Tip Curve LIMA | In distribution |
| AB081211 | Sheath Tip Curve Straight | In distribution |
| AB063007 | Sheath Length 55 cm | In distribution |
| AB073001 | Dilator Length 60 cm | In distribution |
| AB083002 | Sheath Tip Curve RDC | In distribution |
| AB063000 | Dilator Length 50 cm | In distribution |
| AB101073 | Angle 70 ° | In distribution |
| AB083007 | Dilator Length 60 cm | In distribution |
| AB073007 | Sheath Length 55 cm | In distribution |
| AB081040GW | Sheath Length 61 cm | In distribution |
| AB101079 | Dilator Length 84 cm | In distribution |
| AB101076 | Lumen/Inner Diameter 3.5 mm | In distribution |
| AB101077 | Dilator Length 84 cm | In distribution |
| AB063006 | Lumen/Inner Diameter 2.2 mm | In distribution |
| AB083010 | Sheath Tip Curve TD | In distribution |
| AB073003 | Sheath Length 45 cm | In distribution |
| AB073010 | Dilator Length 60 cm | In distribution |
| AB083009 | Sheath Tip Curve TD | In distribution |
| AB063010 | Lumen/Inner Diameter 2.2 mm | In distribution |
| AB083003 | Sheath Tip Curve LIMA | In distribution |
| AB081047 | Lumen/Inner Diameter 2.9 mm | In distribution |
| AB073006 | Sheath Length 45 cm | In distribution |
| AB061204 | Lumen/Inner Diameter 2.2 mm | In distribution |
| AB081047GW | Angle 120 ° | In distribution |
| AB081046GW | Angle 90 ° | In distribution |
| AB081042 | Angle 90 ° | In distribution |
| AB063004 | Dilator Length 60 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Demax | Beijing Demax Medical Technology Co., Ltd. | 2,841 |
| Arrow | Teleflex Medical LLC | 1,036 |
| Prelude IDeal™ | Merit Medical Systems, Inc. | 294 |
| Fast-Cath™ | St. Jude Medical | 213 |
| Flexor | Cook Incorporated | 182 |
| Prelude Ease™ | Merit Medical Systems, Inc. | 176 |
| Performer | Cook Incorporated | 174 |
| VSI | Teleflex Medical LLC | 154 |
| Peel-Away | Cook Incorporated | 153 |
| OptiSeal™ | Greatbatch Medical | 127 |
| Brilliant | Lepu Medical Technology (Beijing) Co., Ltd. | 122 |
| Super Sheath | Togo Medikit Co., Ltd. | 122 |
Showing 12 of 439. All products under Introducer, Catheter
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K210627 | 2021-06-03 |
| K151951 | 2015-09-22 |
| K140917 | 2014-07-09 |
| K140406 | 2014-04-17 |
| K130633 | 2014-02-13 |
| K122958 | 2012-12-13 |
| K122960 | 2012-12-13 |
| K122084 | 2012-08-29 |
| K120459 | 2012-06-29 |
| K101497 | 2010-10-20 |
| K090114 | 2009-06-04 |
| K073100 | 2007-11-30 |
| K890277 | 1989-03-10 |
| K831751 | 1983-10-20 |
Recalls Naming This Product
30 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Oscor Inc. | 510(k) number | 2016-10-05 | Class II | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | 156 | 2019-07-26 |
| Oscor Inc. | 510(k) number | 2016-10-05 | Class II | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | 87 | 2019-07-26 |
| Oscor Inc. | 510(k) number | 2016-10-05 | Class II | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | 30 | 2019-07-26 |
| Oscor Inc. | 510(k) number | 2016-10-05 | Class II | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | 21 | 2019-07-26 |
| Oscor Inc. | 510(k) number | 2016-10-05 | Class II | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | 991 | 2019-07-26 |
| Oscor Inc. | 510(k) number | 2016-10-05 | Class II | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | 76 | 2019-07-26 |
| Oscor Inc. | 510(k) number | 2016-10-05 | Class II | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | 61 | 2019-07-26 |
| Oscor Inc. | 510(k) number | 2016-10-05 | Class II | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | 11 | 2019-07-26 |
| Oscor Inc. | 510(k) number | 2016-10-05 | Class II | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | 26 | 2019-07-26 |
| Oscor Inc. | 510(k) number | 2016-10-05 | Class II | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | 21 | 2019-07-26 |
| Oscor Inc. | 510(k) number | 2016-10-05 | Class II | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | 22 | 2019-07-26 |
| Oscor Inc. | 510(k) number | 2016-10-05 | Class II | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | 70 | 2019-07-26 |
| Oscor Inc. | 510(k) number | 2016-10-05 | Class II | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | 8 | 2019-07-26 |
| Oscor Inc. | 510(k) number | 2016-10-05 | Class II | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | 74 | 2019-07-26 |
| Oscor Inc. | 510(k) number | 2016-10-05 | Class II | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | 124 | 2019-07-26 |
| Oscor Inc. | 510(k) number | 2016-10-05 | Class II | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | 110 | 2019-07-26 |
| Oscor Inc. | 510(k) number | 2016-10-05 | Class II | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | 16 | 2019-07-26 |
| Oscor Inc. | 510(k) number | 2016-10-05 | Class II | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | 34 | 2019-07-26 |
| Oscor Inc. | 510(k) number | 2016-10-05 | Class II | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | 33 | 2019-07-26 |
| Oscor Inc. | 510(k) number | 2016-10-05 | Class II | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | 20 | 2019-07-26 |
| Oscor Inc. | 510(k) number | 2016-10-05 | Class II | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | 255 | 2019-07-26 |
| Oscor Inc. | 510(k) number | 2016-10-05 | Class II | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | 566 | 2019-07-26 |
| Oscor Inc. | 510(k) number | 2016-10-05 | Class II | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | 1,729 | 2019-07-26 |
| Oscor Inc. | 510(k) number | 2016-10-05 | Class II | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | 215 | 2019-07-26 |
| Oscor Inc. | 510(k) number | 2016-10-05 | Class II | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | 186 | 2019-07-26 |
| Oscor Inc. | 510(k) number | 2016-10-05 | Class II | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | 59 | 2019-07-26 |
| Oscor Inc. | 510(k) number | 2016-10-05 | Class II | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | 1,269 | 2019-07-26 |
| Oscor Inc. | 510(k) number | 2016-10-05 | Class II | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | 991 | 2019-07-26 |
| Oscor Inc. | 510(k) number | 2016-10-05 | Class II | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | 55 | 2019-07-26 |
| Oscor Inc. | 510(k) number | 2016-10-05 | Class II | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | 45 | 2019-07-26 |
Recalls
3 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2026-06-10 | Class I | Device Design | Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region. | 32,934 units | |
| 2026-06-10 | Class I | Device Design | Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region. | 355 units | |
| 2026-06-10 | Class I | Device Design | Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region. | 1332 units | |
| 2021-12-22 | Class II | Process control | There is potential for separation between the threaded hub and threaded cap at the proximal end of the device. | 549 units | |
| 2021-03-10 | Class II | Under Investigation by firm | Potential for open seal on sterile product | 500 devices | 2023-08-08 |
| 2008-07-03 | Not classified | Process design | Difficulty breaking the sheath hub and subsequently to peel the sheath off for Introducer Set, Adelante size 7F. | 396 | 2008-12-09 |
| 2005-09-13 | Not classified | Other | Sheath size is larger than dilator size causing insertion difficulties. | 6985 | 2012-07-08 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.