510(k) K173596
- Device
- Rusch Intermittent Urethral Catheters
- Applicant
- Teleflex Medical
- 510(k) number
- K173596
- Product code
- EZC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-01-29
- Date received
- 2017-11-21
- Regulation
- 876.5130
- Classification name
- Catheter, Coude
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Amanda Webb
- Address
- 3015 Carrington Mill Blvd. Morrisville NC US 27560 27560
FDA Registration Numbers#
- 9616088
- 9611590
- 1061124
- 9614279
- 8040607
- 3005636544
- 1423537
- 3013530345
- 3003974574
- 3011137372
- 3009632672
- 1018233
- 3013517171
- 3013557562
- 3005690789
- 3003717263
- 3006553489
- 3011020307
- 1054241
- 3014498861
- 1043214
- 3004111573
- 3010220595
- 2320762
- 1055236
- 3013024191
- 3006082230
- 8040412
Source Documents#
Other 510(k) Records For Product Code EZC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K222279 | Rusch Intermittent Urethral Catheters | Teleflex Medical | 2022-08-29 |
| K946282 | UNIVERSAL URETHRAL CATHETER | Louisville Laboratories, Inc. | 1995-03-31 |
| K913341 | BARD(R) COUDE TIP TEMPERATURE SENSING CATHETER | C.R. Bard, Inc. | 1992-01-27 |
| K910846 | BARD LATEX URINARY CATHETERS DRAINS- DESIGNS MODIF | C.R. Bard, Inc. | 1991-08-16 |
| K910195 | BARD HYDROGEL-COATED FOLEY CATHETERS | C.R. Bard, Inc. | 1991-08-09 |
| K910197 | HYDROGEL-COATED URETHRAL CATHETERS AND DRAINS | C.R. Bard, Inc. | 1991-08-09 |
Legacy Summary#
summary
FDA Review#
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