510(k) K925633
- Device
- BALT INTRODUCER
- Applicant
- TARGET THERAPEUTICS
- 510(k) number
- K925633
- Product code
- DYB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-06-25
- Date received
- 1992-11-09
- Regulation
- 870.1340
- Classification name
- Introducer, Catheter
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- GRACE CARLAND
- Address
- 47201 Lakeview Blvd. P.O. Box 5120 Freemont CA US 94538 94538
FDA Registration Numbers#
- 1423507
- 3008500478
- 2648045
- 9614279
- 9612164
- 9610825
- 3007603855
- 3011237770
- 3007830707
- 1928237
- 1649395
- 1123137
- 1220477
- 3001124136
- 1016427
- 1625425
- 3010220595
- 3008114965
- 1000393132
- 3000268902
- 1721504
- 8043892
- 1526863
- 1724474
- 2030404
- 2521402
- 3010432890
- 2030624
- 2017865
- 1282497
- 3015859709
- 3011396687
- 1820334
- 3005994106
- 9616683
- 3016904853
- 1048735
- 2245270
- 2527072
- 1118880
- 1423537
- 3032916632
- 1000563940
- 1043214
- 3004737415
- 3006283319
- 1221019
- 2246552
- 8020616
- 3010273872
- 3011610434
- 3005232773
- 3020954746
- 2090040
- 3010141307
- 3003915875
- 3004785273
- 3007207906
- 9610847
- 3030574705
- 3041086754
- 2024311
- 2024168
- 3008824097
- 9673241
- 3011024991
- 3015615738
- 1647149
- 3035111606
- 3017689643
- 3011689956
- 3010291427
- 2124215
- 1643817
- 3031571797
- 3013162291
- 1835568
- 2030598
- 3009888344
Source Documents#
Other 510(k) Records For Product Code DYB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261529 | Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04) | Hartman Medical Group, LLC | 2026-07-06 |
| K261242 | SimplGuide | Pendracare | 2026-06-25 |
| K261950 | Health Line Tearaway Introducer | Health Line International Corporation | 2026-06-22 |
| K261492 | FieldFlex Steerable Sheath | CenterPoint Systems, LLC | 2026-06-05 |
| K260606 | Echo Large Bore Introducer Sheath | Echo Medical, LLC | 2026-04-29 |
| K254248 | Introducer Sheath Set | Cardiocycle Medical(Suzhou) Co., Ltd. | 2026-04-23 |
| K254279 | Edwards eSheath+ introducer set | Edwards Lifesciences | 2026-04-17 |
| K260091 | Aventus Introducer Sheath | Inquis Medical | 2026-04-13 |
| K260839 | Protaryx Transseptal Puncture Device (PTX2-001) | Protaryx Medical, Inc. | 2026-04-10 |
| K260942 | AuST Steerable Sheath | CenterPoint Systems, LLC | 2026-04-07 |
| K260459 | VANES Delivery System (VDS) | Zoll Respicardia, Inc. | 2026-04-06 |
| K260626 | Multiflex Steerable Sheath 17.5F | Vizaramed, Inc. | 2026-03-26 |
| K260163 | AuST CSP Introducer | CenterPoint Systems, LLC | 2026-02-19 |
| K254236 | Peel-Away Introducer Sheath | VascuTech Medical, LLC | 2026-02-09 |
| K253652 | Genie MAX Large Bore Introducer Sheath | Cultiv8 1, LLC | 2026-01-22 |
Legacy Summary#
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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