Atlas FDA

NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER

FDA 510(k) clearance K952887 · decided 1995-08-18

Clearance details

K-number
K952887
Device name
NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER
Applicant
Meadox Medicals, Div. Boston Scientific Corp.
Decision
Substantially Equivalent
Date received
1995-06-23
Decision date
1995-08-18
Days to decision
56 days
Clearance type
Traditional
Product code
LJE
Device class
U
Medical specialty
Unknown
Advisory committee
Unknown
Location
Oakland, NJ, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Meadox Medicals

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Disposable Percutaneous Nephrostomy Dilatation Kit (K250448)Shenzhen Trious Medical Technology Co., Ltd.2025-07-03
Introducer Needle (K222705)Youcare Technology Co.,Ltd. (Wuhan)2023-05-22
Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets (K211911)Coloplast Corp.2022-03-10
In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath (K201165)Coloplast Corp.2020-12-17
Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc (K191498)Cook Incorporated2020-01-29
Lawson Retrograde Nephrostomy Wire Puncture Set (K190903)Cook Incorporated2019-12-16
Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set (K183051)Cook Incorporated2019-07-16
Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar Needle (K183035)Cook Incorporated2019-05-17
Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent Set (K181735)Cook Incorporated2019-03-27
Ultraxx Nephrostomy Balloon Catheter Set (K181713)Cook Incorporated2018-08-17
Ultraxx Nephrostomy Balloon Catheter (K171601)Cook Incorporated2018-02-23
Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal Sheath (K172929)Boston Scientific Corporation2018-01-10

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
STRKYER KNEE AUGMENTATION GRAFT (P850054)Meadox Medicals, Div. Boston Scientific Corp.1988-12-30